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 .
Response to Amendment
This is an office action in response to Applicant's arguments and remarks filed on 7/20/2026. Claims 1, 3-13 and 21-24 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to the claims has been withdrawn in view of Applicant's amendment.
The interpretation of claim 7 under 35 U.S.C. 112(f) has been withdrawn in view of Applicant's amendment.
The rejection of claim 2 is obviated by Applicant's cancellation.
All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 112 are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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.
Claim 3 recites the limitation “wherein the first target pressure is in a range of about 200 to about 450 Torr, and the dwell pressure is at least 600 Torr” There is insufficient antecedent basis for the term “the dwell pressure.” For examination purposes, the dwell pressure will be understood to be the second target pressure as recited in claim 1. Clarification is requested.
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.
Claim(s) 1, 3-7, 9-13, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mismar et al. (US 20210077645 A1) in view of Nowruzi et al. (US 20190224356 A1), and Carbone et al. (US 20130230430 A1).
Regarding claim 1, Mismar teaches a method of sterilizing a pre-filled syringe [0003], comprising: placing the pre-filled syringe in a sterilization chamber; and performing a plurality of pulsed sterilization steps (Fig. 7, sterilization process 1, [0048]), wherein each pulsed sterilization step comprises:
humidifying the sterilization chamber [0062];
evacuating the sterilization chamber to a first target pressure, the first target pressure less than ambient pressure (first target pressure can be from 20-500 Torr which is below ambient pressure of 760 Torr, [0062], [0073]);
introducing a quantity of NO2 to the sterilization chamber [0063],
increasing pressure within the sterilization chamber from the first target pressure to a second target pressure, the second target pressure at least about 150 Torr greater than the first target pressure (second target pressure = dwell pressure, which may be approximately 590 torr [0063] or 600 torr [0009]), and exposing the pre-filled syringe to the NO2 in the sterilization chamber at the second target pressure for a dwell period [0063].
Mismar teaches a preconditioning step (Fig. 7, step 4) that occurs prior to a humidification step (Fig. 7, step 5) and wherein the humidification step occurs prior to introducing the quantity of NO2 into the sterilization chamber and to help optimize the killing efficiency of the NO2 [0073]. However, Mismar does not teach wherein the sterilization chamber is dried to a target humidity with the pre-filled syringe therein; wherein the sterilization chamber is humidified after drying the sterilization chamber to a target humidity, and wherein the sterilization chamber is evacuated after humidifying the sterilization chamber. One having ordinary skill in the art would be concerned with ensuring the conditions in the chamber (including humidity and pressure) are optimal prior to the humidification step and the injection of sterilant, motivating one to turn towards Nowruzi.
Nowruzi teaches a method for sterilizing medical devices (Fig. 2) including a load conditioning step (206) that includes drying a sterilization chamber and evacuating the chamber until a target humidity is reached [0031-0032]. Nowruzi teaches the load conditioning step to optimize the conditions of the sterilization container [0028] prior to a sterilization step (208), wherein a chemical sterilant (such as nitrogen dioxide [0040]) is introduced into the chamber [0034].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the preconditioning step as taught by Mismar with the load conditioning step as taught by Nowruzi (including drying a sterilization chamber and evacuating the sterilization chamber) since Nowruzi teaches the load conditioning step to optimize a sterilization chamber for subsequent exposure to a gaseous sterilant such as nitrogen dioxide ([0028], [0040]) and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Accordingly, Modified Mismar teaches a preconditioning step (including drying a sterilization chamber to a target humidity and evacuating the sterilization chamber, Nowruzi, [0028]), a humidifying step (Mismar, Fig. 7, step 6), a sterilant gas injection step (Mismar, Fig. 7, step 7), and an evacuation step that occurs after the humidification step (Mismar, Fig. 7, step 8).
Modified Mismar does not teach wherein the NO2 is introduced from a buffer tank that is selectively fluidly linked to the sterilization chamber; wherein the method comprises a step of passing a predetermined quantity of air through the buffer tank and into the sterilization chamber to aid in rinsing NO2 from the buffer tank into the sterilization chamber; and wherein the dwell period occurs after the quantity of air is passed through the buffer tank.
One having ordinary skill in the art would be concerned with effectively dosing the nitrogen dioxide sterilant to the sterilization chamber motivating one to turn towards Carbone. Carbone teaches a device and method for gas sterilization comprising a sterilization chamber (Fig. 3, 136), a nitrogen dioxide supply tank (Fig. 3, 118), a buffer chamber (Fig. 3, 130), and a control valve configured to allow for the passage of dry air through the buffer chamber (Fig. 3, 132 [0033]). Carbone teaches wherein a valve (Fig. 3, 120) provides a flow of nitrogen dioxide gas from the supply tank into the buffer chamber where it is rinsed with a volume of dry air from valve 182 in order to provide a controlled dosage of nitrogen dioxide to the sterilization chamber [0039-0043].
Carbone is considered analogous to the claimed invention since both are drawn to gaseous sterilization methods. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method as taught by Modified Mismar to include the nitrogen dioxide buffer tank system (including the control valves) and the buffer tank rinsing step as taught by Carbone because Carbone teaches the buffer tank and rinsing step to controlling the dosage of nitrogen dioxide sterilant delivered to a sterilization chamber [0039-0043]. See MPEP 2143(I)(G).
Accordingly, Modified Mismar teaches wherein the dwell period occurs after the air is passed through the buffer tank (Mismar, NO2 is introduced into the sterilization chamber for a dwell period [0063] after passing through the buffer tank taught by Carbone, [0039-0043]).
Regarding claim 3, Modified Mismar teaches the method of claim 1, wherein the first target pressure is in a range of about 200 to about 450 Torr (Mismar, first target pressure can be from 20-500 Torr, [0062], [0073]); and the dwell pressure (understood to be the second target pressure) is at least 600 Torr (Misar, second target pressure = dwell pressure, may be 600 torr [0009]).
Regarding claim 4, Modified Mismar teaches the method of claim 1, wherein the sterilization chamber has a thermal capacity sufficient to prevent the pre-filled syringe from exhibiting a change in temperature of greater than about 5 degrees Celsius from an initial temperature thereof (Mismar, sterilization process of Fig. 1 can be carried out between 2-8 degrees Celsius = understood to have claimed thermal capacity to prevent temperature change within this range [0074]).
Regarding claim 5, Modified Mismar teaches the method of claim 1, but does not explicitly teach wherein a concentration of the NO2 when stored in the buffer tank is about 100 times a concentration of NO2 after introduction into the sterilization chamber.
However, Modified Mismar teaches a plurality of sterilization “recipes” where a plurality of concentrations of nitrogen dioxide doses in the sterilization chamber are contemplated, as well as pressures, and relative humidity (Mismar, [0073]). Thus, one having ordinary skill in the art would recognize the concentration of nitrogen dioxide within the buffer chamber to be a function of the desired dosage configured to be delivered to the sterilization chamber and a result-effective variable. Since this parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to store a concentration of NO2 in the buffer that is about 100 times a concentration of NO2 after introduction into the sterilization chamber.
Regarding claim 6, Modified Mismar teaches the method of claim 1, but does not teach wherein the predetermined quantity of air is in a range of about 4 to about 8 times a volume of the buffer tank.
However, Modified Mismar teaches a plurality of sterilization “recipes” where a plurality of concentrations of nitrogen dioxide doses in the sterilization chamber are contemplated, as well as pressures, and relative humidity (Mismar, [0073]). Thus, one having ordinary skill in the art would recognize the predetermined quantity of air to be passed through the buffer to be a function of the desired dosage configured to be delivered to the sterilization chamber and a result-effective variable. Since this parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to pass a predetermined quantity of air is in the range of about 4 to about 8 times a volume of the buffer tank.
Regarding claim 7, Modified Mismar teaches the method of claim 1, but does not teach wherein the method further comprises: recirculating air in the sterilization chamber; and mixing at least one of water vapor or the NO2 with the recirculated air within the sterilization chamber at the second target pressure.
One having ordinary skill in the art would seek to ensure the syringes are adequately exposed to sterilant, motivating one to turn towards Carbone. Carbone further teaches wherein the sterilization chamber (Fig. 3, 136) comprises a fan that helps circulate gases in the chamber, and a recirculation step that involves using the fan to circulate sterilant gas and humidity in the chamber to adequately expose a target object [0036]
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sterilization chamber and method as taught by Modified Mismar to include the fan and recirculating step as taught by Carbone because Carbone teaches the recirculation step to use the fan to circulate sterilant gas and humidity in the chamber to adequately expose a target object [0036]. See MPEP 2143(I)(G).
Regarding claim 9, Mismar teaches a method of sterilizing a pre-filled syringe [0003], comprising: placing the pre-filled syringe in a sterilization chamber; and performing a plurality of pulsed sterilization steps (Fig. 7, sterilization process 1, [0048]), each of the plurality of pulsed sterilization steps including:
humidifying the sterilization chamber to a second target humidity [0062];
evacuating the sterilization chamber to a first target pressure in a range of about 200 to about 500 Torr (first target pressure may be 20-500 Torr, [0062], [0065], [0073]);
introducing a quantity of NO2 into the sterilization chamber [0063], and
increasing pressure within the sterilization chamber from the first target pressure to a second target pressure, the second target pressure greater than or equal to 600 Torr (second target pressure = dwell pressure, which may be approximately 590 torr [0063] or 600 torr [0009]), and exposing the pre-filled syringe to the NO2 in the sterilization chamber at the second target pressure for a dwell period [0063]; and,
maintaining the second target pressure in the sterilization chamber for a dwell period [0063], wherein a concentration of the NO2 in the sterilization chamber while maintaining the second target pressure in the sterilization chamber is in the range of about 2-20 mg/L ([0071], Tables 1-2).
Mismar teaches a preconditioning step (Fig. 7, step 4) that occurs prior to a humidification step (Fig. 7, step 5) and wherein the humidification step occurs prior to introducing the quantity of NO2 into the sterilization chamber and to help optimize the killing efficiency of the NO2 [0073]. However, Mismar does not teach wherein the sterilization chamber is dried to a first target humidity with the pre-filled syringe therein; wherein the sterilization chamber is humidified to a second target humidity level different from the first target humidity after drying the sterilization chamber to a first target humidity, and wherein the sterilization chamber is evacuated after humidifying the sterilization chamber to a second target humidity. One having ordinary skill in the art would be concerned with ensuring the conditions in the chamber (including humidity and pressure) are optimal prior to the humidification step and the injection of sterilant, motivating one to turn towards Nowruzi.
Nowruzi teaches a method for sterilizing medical devices (Fig. 2) including a load conditioning step (206) that includes drying a sterilization chamber and evacuating the chamber until a target humidity is reached [0031-0032]. Nowruzi teaches the load conditioning step to optimize the conditions of the sterilization container [0028] prior to a sterilization step (208), wherein a chemical sterilant (such as nitrogen dioxide [0040]) is introduced into the chamber [0034].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the preconditioning step as taught by Mismar with the load conditioning step as taught by Nowruzi (including drying a sterilization chamber and evacuating the sterilization chamber) since Nowruzi teaches the load conditioning step to optimize a sterilization chamber for subsequent exposure to a gaseous sterilant such as nitrogen dioxide ([0028], [0040]) and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Accordingly, Modified Mismar teaches a preconditioning step (including drying a sterilization chamber to a target humidity and evacuating the sterilization chamber, Nowruzi, [0028]), a humidifying step (Mismar, Fig. 7, step 6), a sterilant gas injection step (Mismar, Fig. 7, step 7), and an evacuation step that occurs after the humidification step (Mismar, Fig. 7, step 8).
Modified Mismar does not teach wherein the NO2 is introduced from a buffer tank that is selectively fluidly linked to the sterilization chamber; wherein the method comprises a step of passing a predetermined quantity of air through the buffer tank and into the sterilization chamber to aid in rinsing NO2 from the buffer tank into the sterilization chamber; and wherein the dwell period occurs after the quantity of air is passed through the buffer tank.
One having ordinary skill in the art would be concerned with effectively dosing the nitrogen dioxide sterilant to the sterilization chamber motivating one to turn towards Carbone. Carbone teaches a device and method for gas sterilization comprising a sterilization chamber (Fig. 3, 136), a nitrogen dioxide supply tank (Fig. 3, 118), a buffer chamber (Fig. 3, 130), and a control valve configured to allow for the passage of dry air through the buffer chamber (Fig. 3, 132 [0033]). Carbone teaches wherein a valve (Fig. 3, 120) provides a flow of nitrogen dioxide gas from the supply tank into the buffer chamber where it is rinsed with a volume of dry air from valve 182 in order to provide a controlled dosage of nitrogen dioxide to the sterilization chamber [0039-0043].
Carbone is considered analogous to the claimed invention since both are drawn to gaseous sterilization methods. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method as taught by Modified Mismar to include the nitrogen dioxide buffer tank system (including the control valves) and the buffer tank rinsing step as taught by Carbone because Carbone teaches the buffer tank and rinsing step to controlling the dosage of nitrogen dioxide sterilant delivered to a sterilization chamber [0039-0043]. See MPEP 2143(I)(G).
Accordingly, Modified Mismar teaches wherein the dwell period occurs after the air is passed through the buffer tank (Mismar, NO2 is introduced into the sterilization chamber for a dwell period [0063] after passing through the buffer tank taught by Carbone, [0039-0043]).
Regarding claim 10, Modified Mismar teaches the method of claim 9, wherein the second target pressure exceeds the first target pressure by at least 150 Torr (Mismar, second target pressure may be approximately 590 torr [0063] or 600 Torr [0009] and first target pressure can be from 20-500 Torr, [0062], [0073]);
Regarding claim 11, Modified Mismar teaches the method of claim 9, but does not explicitly teach wherein a concentration of the NO2 when stored in the buffer tank is about 100 times a concentration of NO2 after introduction into the sterilization chamber.
However, Modified Mismar teaches a plurality of sterilization “recipes” where a plurality of concentrations of nitrogen dioxide doses in the sterilization chamber are contemplated, as well as pressures, and relative humidity (Mismar, [0073]). Thus, one having ordinary skill in the art would recognize the concentration of nitrogen dioxide within the buffer chamber to be a function of the desired dosage configured to be delivered to the sterilization chamber and a result-effective variable. Since this parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to store a concentration of NO2 in the buffer chamber that is about 100 times a concentration of NO2 after introduction into the sterilization chamber.
Regarding claim 12, Modified Mismar teaches the method of claim 9, but does not teach wherein the predetermined quantity of air is in a range of about 4 to about 8 times a volume of the buffer tank.
However, Modified Mismar teaches a plurality of sterilization “recipes” where a plurality of concentrations of nitrogen dioxide doses in the sterilization chamber are contemplated, as well as pressures, and relative humidity (Mismar, [0073]). Thus, one having ordinary skill in the art would recognize the predetermined quantity of air to be passed through the buffer to be a function of the desired dosage configured to be delivered to the sterilization chamber and a result-effective variable. Since this parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to pass a predetermined quantity of air is in the range of about 4 to about 8 times a volume of the buffer tank.
Regarding claim 13, Modified Mismar teaches the method of claim 9, wherein introducing the quantity of NO2 to the sterilization chamber from the buffer tank is performed by: determining a first pressure in the sterilization chamber (Carbone, [0040]); monitoring a second pressure in the buffer tank (Carbone, [0041-0042]); adding air to the buffer tank until the second pressure exceeds the first pressure (Carbone, [0041-0042]); and opening a valve between the buffer tank and the sterilization chamber to communicate the NO2 from the buffer tank into the sterilization chamber (Carbone, [0039-0044]).
Regarding claim 22, Modified Mismar teaches the method of claim 1, wherein the dwell period is greater than 0 minutes and less than or equal to about 4 minutes (Mismar, dwell time can be between 2-7 minutes [0064]).
Regarding claim 24, Modified Mismar teaches the method of claim 9, wherein the dwell period is greater than 0 minutes and less than or equal to about 4 minutes (Mismar, dwell time can be between 2-7 minutes [0064]).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mismar et al. (US 20210077645 A1) in view of Nowruzi et al. (US 20190224356 A1), and Carbone et al. (US 20130230430 A1).as applied to claim 1 above, further in view of Arnold et al. (US 20080317626 A1).
Regarding claim 8, Modified Mismar teaches the method of claim 1, but does not teach wherein the introduced NO2 is at least partly converted to other chemical products during sterilization, the other chemical products including at least HONO, and the method further comprises monitoring a concentration of HONO during the sterilization procedure, comparing the concentration of HONO to one or more thresholds, and determining that the sterilization procedure is incomplete if the concentration of HONO does not meet the one or more thresholds.
Arnold teaches a sterilization system and method utilizing nitric oxide and nitrogen dioxide [0009] that is introduced into a sterilization chamber [0047]. Arnold teaches that the presence of nitrogen oxides in humid environments may generate nitrous acid, which improve the efficiency of the sterilization process [0029]. Arnold also teaches the optimization of humidity [0084] and ambient air [0101] during the process to yield an adequate concentration of nitrous acid and contemplates that an inadequate generation of nitrous acid formed during the process would lead to a reduced sterilization efficiency (understood to be monitoring nitrous acid concentration, comparing nitrous acid to a threshold, determining the sterilization process is incomplete based on the concentration [0098], [0101-0102]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method as taught by Modified Mismar to include the optimization of air/humidity step as taught by Arnold since Arnold teaches the optimization to yield a measurable amount of nitrous acid which can be used to determine the efficiency of sterilization ([0098], [0101-0102]) and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143 (I)(A).
Claim(s) 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mismar et al. (US 20210077645 A1) in view of Nowruzi et al. (US 20190224356 A1), and Carbone et al. (US 20130230430 A1), further in view of Olson et al. (US 9017607 B2) (cited in Applicant’s IDS dated 7/20/2026).
Regarding claim 21, Modified Mismar teaches the method of claim 1, wherein the second target pressure can be 600 Torr (Mismar, [0009]) but does not teach wherein the second target pressure can be in a range from about 100 Torr below ambient pressure (660 Torr) to ambient pressure (760 Torr).
One having ordinary skill in the art would seek to optimize the dwell pressure of a sterilization chamber containing a gaseous sterilant and a target object, motivating one to turn towards Olson. Olson teaches a decontamination system and method comprising a sterilization chamber configured to hold a medical device and a chemical assembly configured to dispense a decontaminating fluid within the chamber, wherein the chamber is at a sub-atmospheric pressure prior to the decontaminating fluid being injected (Fig. 2, step 100 = evacuating chamber to a first target pressure, steps 102/104 inject decontaminating fluid into the chamber while increasing pressure within the chamber). After the injection of fluid, Olson teaches the chamber to be held at a “hold pressure” for a specified period of time (understood be a second target pressure during a dwell time) wherein the hold pressure can be 760 Torr (understood to be ambient pressure to ambient pressure, Fig. 2, step 106, col. 7, lns.18-28) in order adequately decontaminate the medical device disposed within (col. 7, lns. 30-35).
Olson is considered analogous to the claimed invention since both are drawn to decontamination systems and methods. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the second target pressure as taught by Modified Mismar to be ambient pressure as taught by Olson because Olson teaches the pressure to be optimal for exposing a medical device to a gaseous decontaminate for a dwell time (col. 7, lns. 30-35) and this involves the combination of elements (the dwell step of Modified Mismar and the dwell pressure of Olson) to yield a predictable result (a dwell pressure/second target pressure of 760 Torr [ambient pressure] that adequately sterilizes a target object) with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Regarding claim 23, Modified Mismar teaches the method of claim 9, wherein the second target pressure can be 600 torr (Mismar, [0009]) but does not teach wherein the second target pressure can be in a range from about 100 Torr below ambient pressure (660 Torr) to ambient pressure (760 Torr).
Response to Arguments
In the arguments presented on pages 8-10 of the amendment, filed 7/20/2026, the Applicant argues that Mismar does not teach increasing pressure within the sterilization chamber from the first target pressure to a second target pressure, wherein the second target pressure is at least 150 torr greater than the first target pressure, and exposing the pre-filled syringe to the NO2 in the sterilization chamber at the second target pressure for a dwell period with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103.
This argument has been fully considered and is unpersuasive. Mismar teaches increasing the pressure from a first target pressure of 20-500 Torr (which is below ambient pressure of 760 Torr, [0062], [0073]) to a second target pressure that is at least 150 Torr greater than the first target pressure (second target pressure = dwell pressure, which may be approximately 590 torr [0063] or 600 torr [0009]) a exposing the pre-filled syringe to the NO2 in the sterilization chamber at the second target pressure for a dwell period [0063].
However, the rejection has been withdrawn in light of the amendment and a new ground(s) of rejection is made in view of the prior art Carbone et al. (US 20130230430 A1).
In the arguments presented on page 9-10 of the amendment, filed 7/20/2026, the Applicant argues that the buffer tank of Takahashi is structurally and functionally different than the claimed buffer tank because Takahashi teaches the buffer tank to hold a hydrogen peroxide sterilant instead of nitrogen dioxide sterilant with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art Carbone et al. (US 20130230430 A1).
In the arguments presented on pages 9-10 of the amendment, filed 7/20/2026, the Applicant argues that Cookson teaches a sterilant reservoir configured to hold a liquid sterilant that are introduced into a sterilization chamber via a carrier gas which and does not teach passing a predetermined quantity of air through a buffer tank and into a sterilization chamber to aid in the rinsing of a sterilant from the buffer tank with respect to the rejection(s) of claim(s) 1 and 9 under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art Carbone et al. (US 20130230430 A1).
In the arguments presented on pages 8-10 of the amendment, filed 7/20/2026, the Applicant argues that Cookson teaches a sterilant reservoir configured to hold liquid sterilants that are introduced into a sterilization chamber via a carrier gas which and does not teach passing a predetermined quantity of air through a buffer tank and into a sterilization chamber to aid in the rinsing of a sterilant from the buffer tank with respect to the rejection(s) of claim(s) 1 and 9 under 35 U.S.C. 103.
This argument has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art Carbone et al. (US 20130230430 A1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130236373 A1 teaches a metering unit for a sterilant which is understood to function as a buffer tank
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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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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