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 .
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-13, in the reply filed on 11/25/2025 is acknowledged.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1, please change all instances of “NO2” to “NO2” in claim 1 and all dependent claims
Claim 9, please change all instances of “NO2” to “NO2” in claim 9 and all dependent claims
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Specifically, the term “circulations means” is being interpreted in light of the disclosed structure in the specification [0033] and will be understood to include a fan, blower, and all equivalent structures.
Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claims 1, 4-5, and 7 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.
Claim 1 recites “drying the sterilization chamber to a target” in line 5. It is unclear what the target is. For examination purposes, it will be understood to be a target humidity.
Claim 4 recites “wherein the sterilization chamber has a thermal capacity sufficient to prevent a change in temperature of the pre-filled syringe during the sterilization process to less than 5 degrees C”. It is not clear whether the method is preventing the syringe from dropping below 5 degrees or keeping the syringe from dropping in temperature by more than 5 degrees due to double negative terms. For examination purposes, the claim will be interpreted as the latter. It is suggested to amend the claim to recite "maintain a change in temperature of less than 5 degrees,” "prevent a change in temperature of more than 5 degrees,” or a similar phrasing to cure the indefiniteness issue.
Claim 5 recites the limitation "buffer chamber" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it will be understood to be referring to the buffer tank.
Claim 7 recites the limitation “wherein the steps of humidifying and introducing the quantity of NO2 are performed by mixing with the recirculating air while the chamber is at a pressure below ambient pressure.” It is unclear what exactly is being mixed with the recirculating air and if Applicant is referring to the nitrogen dioxide, the water vapor, or both. Clarification is requested.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-7 and 9-13 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), Takahashi et al. (US 20210299306 A1), and Cookson et al. (US 20200306401 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 target pressure [0062]; introducing a quantity of NO2 to the sterilization chamber [0063], and holding the sterilization chamber for a dwell period at a dwell pressure [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, 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 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 sourced 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 delivering the nitrogen dioxide sterilant to the sterilization chamber motivating one to turn towards Takahashi, who teaches a sterilizing method utilizing ozone and hydrogen peroxide [abstract]. Takahashi further teaches a buffer tank (Fig. 1, 34) in fluid communication with an ozone generator (Fig. 1, 32) and a sterilization chamber wherein the direct injection of ozone sterilant into the chamber increases the speed of diffusion and concentration within said chamber which one having ordinary skill in the art would recognize and increasing sterilization efficiency [0046].
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 as taught by Modified Mismar to include a sterilant buffer tank as taught by Takahashi to improve the speed of sterilant diffusion and concentration withing the sterilization chamber 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).
Modified Mismar teaches a buffer tank but does not teach 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 moving all the sterilant contained in the buffer tank into the sterilization chamber motivating one to turn towards Cookson, who teaches a method and system for sterilizing an enclosed vessel [abstract]. Cookson teaches an enclosed vessel (Fig. 1, 20) fluidically coupled to a sterilant reservoir which contains a vaporizable sterilant (Fig. 1, 30, [0022-0023]) that is moved from the reservoir into the vessel with purified air from a carrier gas reservoir (40) to mix and mobilize the sterilant vapor into the vessel [0027-0028].
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 buffer chamber as taught by Modified Mismar to include an air compressor and purified gas reservoir as taught by Cookson to aid with the mixing and mobilization of the sterilant into the sterilization chamber and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A).
Modified Mismar teaches a sterilant buffer tank in fluidic connection with a sterilization chamber (Takahashi, [0046]) and a purified gas reservoir configured to pass a quantity of air through the buffer tank and into the sterilization chamber to aid in rinsing sterilant from the buffer tank (Cookson, [0027-0028]) during the step of introducing a quantity of NO2 to the sterilization chamber (Mismar, [0063]), which occurs prior to holding the sterilization chamber for a dwell period at a dwell pressure (Mismar, [0063]).
Regarding claim 2, Modified Mismar teaches the method of claim 1, wherein the dwell pressure exceeds the target pressure by at least 150 Torr (Mismar, dwell pressure may be approximately 590 torr [0063] and target vacuum pressure may be between 150-400 torr [0065]).
Regarding claim 3, Modified Mismar teaches the method of claim 1, wherein the target pressure is in the range of about 200 to about 500 Torr, and the dwell pressure is about 600 Torr (Mismar, target vacuum pressure may be between 150-300 torr [0065]) and dwell pressure is approximately 590 torr which one of ordinary skill in the art would consider to be within the range of “about 600 Torr”).
Regarding claim 4, Modified Mismar teaches the method of claim 1, wherein the sterilization chamber has a thermal capacity sufficient to prevent a change in temperature of the pre-filled syringe during the sterilization process to less than 5 degrees C (Mismar, sterilization process of Fig. 1 can be carried out between 2-8 degrees C = understood to have claimed thermal capacity to prevent temperature change within this range [0074], see 112 rejection above).
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 chamber 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 100 times 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 the range of 4-8 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 4-8 times a volume of the buffer tank.
Regarding claim 7, Modified Mismar teaches the method of claim 1, wherein a circulation means is provided for recirculating air in the chamber, and wherein the steps of humidifying and introducing the quantity of NO2 are performed by mixing with the recirculating air while the chamber is at a pressure below ambient pressure (Nowruzi, air during humidification step is circulated under a vacuum [0028], Cookson, compressor facilitates circulation of sterilant in sterilization chamber [0028] while the chamber is under a vacuum, [0011], [0029]).
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]), wherein each pulsed sterilization step comprises humidifying the sterilization chamber [0062]; evacuating the sterilization chamber to a target pressure of about 200 to about 500 Torr [0062, 0065]; introducing a quantity of NO2 to the sterilization chamber [0063], and holding the sterilization chamber for a dwell period at a dwell pressure of about 600 Torr or more ([[0063], dwell pressure is approximately 590 torr which one of ordinary skill in the art would consider to be within the range of “about 600 torr”), wherein a concentration of the NO2 in the sterilization chamber during the dwell step 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 target humidity level with the pre-filled syringe therein; wherein the sterilization chamber is humidified after drying the sterilization chamber to a target level, and wherein the sterilization chamber is evacuated after humidifying the sterilization chamber to a target pressure. 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).
Modified Mismar does not teach wherein the NO2 is sourced 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 delivering the nitrogen dioxide sterilant to the sterilization chamber motivating one to turn towards Takahashi, who teaches a sterilizing method utilizing ozone and hydrogen peroxide [abstract]. Takahashi further teaches a buffer tank (Fig. 1, 34) in fluid communication with an ozone generator (Fig. 1, 32) and a sterilization chamber wherein the direct injection of ozone sterilant into the chamber increases the speed of diffusion and concentration within said chamber which one having ordinary skill in the art would recognize and increasing sterilization efficiency [0046].
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 as taught by Modified Mismar to include a sterilant buffer tank as taught by Takahashi to improve the speed of sterilant diffusion and concentration withing the sterilization chamber 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).
Modified Mismar teaches a buffer tank but does not teach 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 moving all the sterilant contained in the buffer tank into the sterilization chamber motivating one to turn towards Cookson, who teaches a method and system for sterilizing an enclosed vessel [abstract]. Cookson teaches an enclosed vessel (Fig. 1, 20) fluidically coupled to a sterilant reservoir which contains a vaporizable sterilant (Fig. 1, 30, [0022-0023]) that is moved from the reservoir into the vessel with purified air from a carrier gas reservoir (40) to mix and mobilize the sterilant vapor into the vessel [0027-0028].
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 buffer chamber as taught by Modified Mismar to include an air compressor and purified gas reservoir as taught by Cookson to aid with the mixing and mobilization of the sterilant into the sterilization chamber and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A).
Modified Mismar teaches a sterilant buffer tank in fluidic connection with a sterilization chamber (Takahashi, [0046]) and a purified gas reservoir configured to pass a quantity of air through the buffer tank and into the sterilization chamber to aid in rinsing sterilant from the buffer tank (Cookson, [0027-0028]) during the step of introducing a quantity of NO2 to the sterilization chamber (Mismar, [0063]), which occurs prior to holding the sterilization chamber for a dwell period at a dwell pressure (Mismar, [0063]).
Regarding claim 10, Modified Mismar teaches the method of claim 9, wherein the dwell pressure exceeds the target pressure by at least 150 Torr (Mismar, dwell pressure may be approximately 590 torr [0063] and target vacuum pressure may be between 150-400 torr [0065]).
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 chamber 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 100 times 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 the range of 4-8 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 4-8 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 first pressure in the sterilization chamber; monitoring a second pressure in the buffer tank; adding air to the buffer tank until the second pressure exceeds the first pressure; and opening a valve between the buffer tank and the sterilization chamber (Cookson, compressor pressurizes sterilant in buffer tank and introduces the sterilant to the sterilization chamber [which is at a predestined vacuum pressure] via a valve [0010-0011], [0028]).
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), Takahashi et al. (US 20210299306 A1), and Cookson et al. (US 20200306401 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200101186 A1 teaches a sterilization method for syringes using vaporized sterilant.
US 9731041 B2 teaches a nitrogen oxide sterilization method.
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/N.S.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758