DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This is an office action in response to Applicant's arguments and remarks filed on 12/18/2025. Claims 1-23 are pending in the application and are being examined herein.
Status of Objections and Rejections
3. All rejections from the previous office action are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Response to Arguments
4. In the arguments presented on p.2 of the amendment, the Applicant argues that Shodder does not teach the claim 1, 10, and 18 limitations of “wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load,” and “a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase”.
Applicant’s arguments, see p.2, filed 12/28/2025, with respect to the rejection(s) of claim(s) 1, 10, and 18 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shodder (WO 2018182929 A1), further in view of Matsuo et al. (WO 2020183696 A1).
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-6, 10-18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shodder (WO 2018182929 A1), further in view of Matsuo et al. (WO 2020183696 A1).
Regarding claim 1, Shodder teaches a sterilization method comprising: pre-conditioning (step 204, Fig. 2) a sterilization apparatus including a sterilization chamber (sterilization chamber 102, Fig. 1) comprising a sterilization load (products 105 as the sterilization load, Fig. 1),
executing a sterilization phase (step 206, Fig. 2), wherein the sterilization phase includes a plurality of sterilization pulses (see claim 3, “between 2 and 5 sterilization pulses”); and a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase (“maintaining a temperature of between about 25°C and about 60°C within the chamber while performing the sterilization pulse” as mentioned in claim 24 can be less than or equal to the maximum temperature of the sterilization load of 30°C with a range of 25-30°C); and
executing an aeration phase (step 208, Fig. 2), wherein the aeration phase includes a plurality of aeration pulses (see claim 18, “between 2 and 35 aeration pulses”), wherein the plurality of aeration pulses includes:
a primary aeration pulse comprising: achieving a first vacuum pressure within the sterilization chamber (step 342, Fig. 3C), wherein the first vacuum pressure is 500 to 800 millibar (“such as between about 500 millibars and about 800 millibars, [070]); and
after a first vacuum hold (step 344 , Fig. 3C), increasing the pressure of the sterilization chamber to a pressure greater than 700 millibar (step 346, Fig. 3C); and
a secondary aeration pulse comprising: achieving a second vacuum pressure within the sterilization chamber (step 322, Fig. 3B), wherein the second vacuum pressure is less than 650 millibar; and
after a second vacuum hold (step 324, Fig. 3B), adding air to the sterilization chamber while exhausting the sterilization apparatus (steps 326, 328, Fig. 3B).
Shodder teaches a VHP injector as a means of supplying vaporized hydrogen peroxide (132, Fig. 1), but is silent on wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load. The VHP injector does not recite any temperature feature, but merely mentions that it is a source of VHP having an aqueous component ([056]). It is important to note that the maximum temperature of the sterilization load is deemed as 30°C ([030]).
Matsuo teaches a sterilization system for an object by utilizing hydrogen peroxide as the sterilant (abstract), to which the means of VHP supply is generated by a storage tank holding an aqueous liquid solution of hydrogen peroxide (24, Fig. 1) connected to an evaporator (26, Fig. 1) that is “kept constant at a predetermined temperature, for example, between 65 and 120°C” (p.4, 2nd paragraph of English translation) in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (p.4, 1st paragraph of English translation).
Shodder and Matsuo are analogous references, both directed to sterilization systems for an object by utilizing hydrogen peroxide as the sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the VHP injector of Shodder by incorporating a storage tank holding liquid aqueous hydrogen peroxide solution connected to an evaporator that is kept constant at temperatures ranging from 65-120°C as taught by Matsuo in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (Matsuo, p.4, 1st paragraph of English translation).
With this modification, because Matsuo’s evaporator is kept at a temperature between 65-120°C at all times (“constant”), this would inherently include the time period before the VHP injection/sterilization phase (i.e., preconditioning).
Regarding claim 2, modified Shodder teaches wherein the plurality of aeration pulses includes a first primary aeration pulse, followed by a first secondary aeration pulse, followed by a second primary aeration pulse, followed by a second secondary aeration pulse (see [068]).
Regarding claim 3, modified Shodder teaches wherein the portion of the sterilization apparatus includes an inlet and a conduit (inlet conduit 134) connecting a VHP injector (VHP injector 132) to the inlet.
Regarding claim 4, modified Shodder teaches wherein each sterilization pulse comprises: achieving a sterilization pressure within the sterilization chamber ; and when the sterilization chamber is at the sterilization pressure, adding vaporized hydrogen peroxide to the sterilization chamber (see claim 1, “performing a sterilization pulse comprising: maintaining a sterilization pressure within the chamber for at least 5 minutes; introducing vaporized hydrogen peroxide (VHP) into the chamber”).
Regarding claim 5, modified Shodder teaches wherein the sterilization pressure is less than or equal to 650 millibars (see claim 2, “the method of claim 1, wherein the sterilization pressure is between about 400 millibars and about 800 millibars”).
Regarding claim 6, modified Shodder teaches further comprising: after the sterilization phase and prior to the aeration phase, adding a dry air to the sterilization chamber (dry air supply 130, Fig. 1, and “introducing dry gas into the chamber” after the sterilization pulses, where the sterilization pulses are before the aeration phase, just after the sterilization via VHP injection, see claim 1 and Fig. 2).
Regarding claim 10, modified Shodder teaches a sterilization method comprising: pre-conditioning (step 204, Fig. 2) a sterilization apparatus (100, Fig. 1) including a sterilization chamber (sterilization chamber 102, Fig. 1) comprising a sterilization load (products 105 as the sterilization load, Fig. 1),
temperature of the sterilization load throughout the sterilization phase (“maintaining a temperature of between about 25°C and about 60°C within the chamber while performing the sterilization pulse” as mentioned in claim 24 can be less than or equal to the maximum temperature of the sterilization load of 30°C with a range of 25-30°C), the sterilization phase includes first, second, and third sterilization pulses (see claim 3, “between 2 and 5 sterilization pulses”),
wherein each sterilization pulse includes: achieving a sterilization pressure within the sterilization chamber (step 302, Fig. 3A); and
when the sterilization chamber is at the sterilization pressure, adding an amount of vaporized hydrogen peroxide to the sterilization chamber (step 304, Fig. 3A); and
executing an aeration phase (step 208, Fig. 2) comprising: achieving a vacuum pressure within the sterilization chamber (step 322, Fig. 3B), wherein the vacuum pressure is less than 650 millibar; and
after a vacuum hold (step 324, Fig. 3B), adding air to the sterilization chamber while exhausting the sterilization apparatus (step 326, Fig. 3B);
wherein the amount of vaporized hydrogen peroxide added to the sterilization chamber during the first sterilization pulse is sufficient to establish a lethal concentration of hydrogen peroxide in the chamber (claim 39 mentions “wherein the VHP includes a vaporized aqueous hydrogen peroxide solution having a concentration of about 35% hydrogen peroxide by weight”, where the VHP is to terminally sterilize medical products, see Abstract);
the amount of vaporized hydrogen peroxide added to the sterilization chamber during the second sterilization pulse is less than the amount of vaporized hydrogen peroxide added to the sterilization chamber during the first sterilization pulse; and the amount of vaporized hydrogen peroxide added to the sterilization chamber during the second sterilization pulse is less than the amount of vaporized hydrogen peroxide added to the sterilization chamber during the third sterilization pulse (the amounts of VHP can be manipulated with each sterilization pulse via controller 140, Fig. 1… “It will be recognized that the customizable and controllable aspects of sterilization system 100 may be used in order to carry out phases and steps depicted in FIGS. 2 and 3A-3C. For example, in some embodiments, controller 140 may be employed to direct, adjust, or modify a series of sterilization steps, setpoints, and phases performable by sterilization system 100, see [043], [048], to which [057] lists out the possible injected VHP amounts in the sterilization chamber, where a combination of the amounts would read on this limitation).
Shodder teaches a VHP injector as a means of supplying vaporized hydrogen peroxide (132, Fig. 1), but is silent on wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load. The VHP injector does not recite any temperature feature, but merely mentions that it is a source of VHP having an aqueous component ([056]). It is important to note that the maximum temperature of the sterilization load is deemed as 30°C ([030]).
Matsuo teaches a sterilization system for an object by utilizing hydrogen peroxide as the sterilant (abstract), to which the means of VHP supply is generated by a storage tank holding an aqueous liquid solution of hydrogen peroxide (24, Fig. 1) connected to an evaporator (26, Fig. 1) that is “kept constant at a predetermined temperature, for example, between 65 and 120°C” (p.4, 2nd paragraph of English translation) in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (p.4, 1st paragraph of English translation).
Shodder and Matsuo are analogous references, both directed to sterilization systems for an object by utilizing hydrogen peroxide as the sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the VHP injector of Shodder by incorporating a storage tank holding liquid aqueous hydrogen peroxide solution connected to an evaporator that is kept constant at temperatures ranging from 65-120°C as taught by Matsuo in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (Matsuo, p.4, 1st paragraph of English translation).
With this modification, because Matsuo’s evaporator is kept at a temperature between 65-120°C at all times (“constant”), this would inherently include the time period before the VHP injection/sterilization phase (i.e., preconditioning).
Regarding claims 11 and 12, modified Shodder teaches wherein the first sterilization pulse is repeated at least once before the second sterilization pulse and wherein the third sterilization pulse is repeated at least twice (see claim 3, “between 2 and 5 sterilization pulses”, and “some phases and/or steps in FIGS. 2 and 3A-3C may be omitted, combined, and/or performed out of order… the customizable and controllable aspects of sterilization system 100 may be used in order to carry out phases and steps depicted in FIGS. 2 and 3A-3C. For example, in some embodiments, controller 140 may be employed to direct, adjust, or modify a series of sterilization steps, setpoints, and phases performable by sterilization system 100”, [043], suggesting that sterilization pulses can be repeated through the controller).
Regarding claim 13, modified Shodder teaches wherein the amount of vaporized hydrogen peroxide added to the sterilization chamber during the first sterilization pulse includes at least 0.1 moles of hydrogen peroxide per cubic meter of volume of the sterilization chamber (“an injected supply of VHP may be between about 0.2 and about 2.0 grams per cubic foot, such as about 0.25 grams, about 0.50 grams, about 0.75 grams, about 1.0 gram, about 1.2 grams, about 1.4 grams, about 1.5 grams, about 1.6 grams, about 1.8 grams, or about 2.0 grams per cubic foot”, [057]).
Regarding claim 14, modified Shodder teaches wherein each sterilization pulse further includes: (i) adding gas into the sterilization chamber to increase the pressure to a hold pressure (step 308, Fig. 3A), wherein the hold pressure is greater than 700 millibar (“The gas may be injected in a volume to achieve a pressure between about 500 millibars and about 1 100 millibars, such as between about 550 millibars and about 1000 millibars, between about 600 millibars and about 1000 millibars, between about 700 millibars and about 700 millibars and about 900 millibars, or between about 750 millibars and about 850 millibars. For example, the second post-injection pressure may be about 700 millibars, about 750 millibars, about 800 millibars, about 850 millibars, or about 900 millibars”, [060]); and (ii)
decreasing the pressure of the sterilization chamber to the sterilization pressure (cycling back to step 302, Fig. 3A).
Regarding claim 15, modified Shodder teaches the sterilization pulse steps (see claim 14 rejection above), where the time on each pulse is manipulatable ([030]), but is silent to wherein step (i) takes more time than step (ii).
Matsuo teaches a sterilization system for an object by utilizing hydrogen peroxide as the sterilant (abstract), to which in Fig. 10 shows a time vs. pressure graph that has a post-transition hold H36, and a lowering of pressure back to the sterilization pressure where sterilization pulse 2 starts, wherein the time in H36 is greater than the time to depressurize back to sterilization pressure.
Shodder and Matsuo are analogous references, both directed to sterilization systems for an object by utilizing hydrogen peroxide as the sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the sterilization pulse steps of Shodder with the time parameters of step (i)/H36 being longer than the depressurization time as taught by Matsuo because the combination of this feature would yield the predictable result of sterilizing the object via a sterilant through a series of sterilization pulse steps.
Regarding claim 16, modified Shodder teaches wherein each sterilization pulse further comprises: before step (i), maintaining the pressure of the sterilization chamber for a first hold time (step 306, Fig. 3A), after step (ii), maintaining the pressure of the sterilization chamber for a second hold time (step 310, Fig. 3A), wherein the second hold time is longer than the first hold time (first hold time correlating to post-injection hold time of step 306 can be 2 minutes, see [059], and the second hold time correlating to post-transition hold time of step 310 can be at least 5 minutes, see [061]).
Regarding claim 17, modified Shodder teaches a wherein the sterilization chamber includes a distribution manifold (107), an inlet (109), and a chamber wall (walls encapsulated by temperature control jacket 104, Fig. 1), and the method further comprises: during the first, second, and third sterilization pulses, maintaining a temperature of the chamber wall to be approximately the same as a temperature of the inlet or a temperature of the distribution manifold (temperature control jacket 104, hooked up to the controller 140, able to manipulate chamber wall temperature to inlet/manifold temperature, see [032] and Fig. 1).
Regarding claim 18, modified Shodder teaches a sterilization method comprising: pre-conditioning (step 204, Fig. 2) a sterilization apparatus (100, Fig. 1) including a sterilization chamber (sterilization chamber 102, Fig. 1) comprising a sterilization load (products 105 as the sterilization load, Fig. 1); and
a first sterilization pulse including adding a first amount of vaporized hydrogen peroxide to the sterilization chamber (step 304, Fig. 3A), wherein the first amount is sufficient to establish a lethal concentration of hydrogen peroxide in the sterilization chamber (claim 39 mentions “wherein the VHP includes a vaporized aqueous hydrogen peroxide solution having a concentration of about 35% hydrogen peroxide by weight”, where the VHP is to terminally sterilize medical products, see Abstract);
a plurality of second sterilization pulses (see claim 3, “between 2 and 5 sterilization pulses”), wherein each second sterilization pulse includes adding a second amount of vaporized hydrogen peroxide to the sterilization chamber, wherein the second amount is less than the first amount; and a plurality of third sterilization pulses, wherein each third sterilization pulse includes adding a third amount of vaporized hydrogen peroxide to the sterilization chamber, wherein the third amount is less than the second amount (the amounts of VHP can be manipulated with each sterilization pulse via controller 140, Fig. 1… “It will be recognized that the customizable and controllable aspects of sterilization system 100 may be used in order to carry out phases and steps depicted in FIGS. 2 and 3A-3C. For example, in some embodiments, controller 140 may be employed to direct, adjust, or modify a series of sterilization steps, setpoints, and phases performable by sterilization system 100”, see [043], [048], to which [057] lists out the possible injected VHP amounts in the sterilization chamber, where a combination of the amounts would read on this limitation);
wherein, throughout the sterilization method, a temperature of the sterilization chamber is less than or equal to the maximum temperature of the sterilization load throughout the sterilization phase (“maintaining a temperature of between about 25°C and about 60°C within the chamber while performing the sterilization pulse” as mentioned in claim 24 can be less than or equal to the maximum temperature of the sterilization load of 30°C with a range of 25-30°C).
Shodder teaches a VHP injector as a means of supplying vaporized hydrogen peroxide (132, Fig. 1), but is silent on wherein pre-conditioning the sterilization apparatus includes increasing a temperature of a portion of the sterilization apparatus to a temperature greater than a maximum temperature of the sterilization load. The VHP injector does not recite any temperature feature, but merely mentions that it is a source of VHP having an aqueous component ([056]). It is important to note that the maximum temperature of the sterilization load is deemed as 30°C ([030]).
Matsuo teaches a sterilization system for an object by utilizing hydrogen peroxide as the sterilant (abstract), to which the means of VHP supply is generated by a storage tank holding an aqueous liquid solution of hydrogen peroxide (24, Fig. 1) connected to an evaporator (26, Fig. 1) that is “kept constant at a predetermined temperature, for example, between 65 and 120°C” (p.4, 2nd paragraph of English translation) in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (p.4, 1st paragraph of English translation).
Shodder and Matsuo are analogous references, both directed to sterilization systems for an object by utilizing hydrogen peroxide as the sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the VHP injector of Shodder by incorporating a storage tank holding liquid aqueous hydrogen peroxide solution connected to an evaporator that is kept constant at temperatures ranging from 65-120°C as taught by Matsuo in order to evaporate the aqueous hydrogen peroxide solution and supply as needed to the sterilization chamber (Matsuo, p.4, 1st paragraph of English translation).
With this modification, because Matsuo’s evaporator is kept at a temperature between 65-120°C at all times (“constant”), this would inherently include the time period before the VHP injection/sterilization phase (i.e., preconditioning).
Regarding claim 22, modified Shodder teaches placing the syringe inside a sterilization chamber (abstract mentions pre-filled syringes to be sterilized, see [031]); and subjecting the syringe to the sterilization method of claim 1 (sterilization load, see [026] and [031]).
Regarding claim 23, Shodder in view of Matsuo teaches wherein pre-conditioning (step 204, Fig. 2) the sterilization apparatus (Shodder, sterilization apparatus 100, Fig. 1) includes increasing the temperature of the portion of the sterilization apparatus to at least 110°C (Matsuo, evaporator 26 is kept at constant temperature between 65-120°C, inherently including the time period before the VHP injection/sterilization phase (i.e., preconditioning), for the same modification purpose of claim 1 rejection above, and one cannot achieve a constant temperature that includes above 110°C without first increasing the evaporator’s temperature).
7. Claims 7-9 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shodder (WO 2018182929 A1) in view of Matsuo et al. (WO 2020183696 A1), as applied to claim 1 and 18 above, further in view of Herrig et al. (US 20200330634 A1).
Regarding claim 7, modified Shodder teaches the manipulability of pressure within the sterilization chamber ([030], where blower 106 and vacuum pump 110 form a closed system, Fig. 1 and [035]), but fails to teach specifically a piston or diaphragm configured to adjust the pressure of the sterilization chamber, wherein after the sterilization phase, creating a low frequency pressure wave with the piston or diaphragm.
Herrig teaches a sterilization system for an object (abstract and system 100, Fig. 1) that utilizes a diaphragm (208, Fig. 2) as part of a pressure pulse generator (200, Fig. 2) in order to adjust the pressure of the sterilization chamber (see [0038], [0040] and Fig. 2) after a sterilization phase (“A sterilant fluid is delivered to the decontamination chamber. Next, a plurality of flow oscillations are applied to an interior of the decontamination chamber to agitate flow within the decontamination chamber”, [0009]). The pressure pulse generator creates a low-frequency pressure wave (oscillations from generator 200, Fig. 2) within the closed system of the chamber and the pulse generator (Fig. 1, where pressure generator 136 is replaced with the pressure generator 200 of Fig. 2, see [0038]) in order to “increase flow of sterilant fluid in the device, which may result in better exposure of the device to the sterilant fluid” ([0020]).
Modified Shodder and Herrig are analogous references, both directed to sterilization chambers utilizing pressure changes and sterilant fluid to sterilize an object.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to modify modified Shodder’s pressure control means of the blower and/or the vacuum pump by incorporating a diaphragm-piston pulse generator creating low-frequency oscillations within the chamber as taught by Herrig in order to “agitate flow within the decontamination chamber” (Herrig, [0009]) and increase exposure of the device to the sterilant fluid (Herrig, [0020]).
Regarding claim 8, modified Shodder teaches the liquid hydrogen peroxide being on contact with the sterilization load (VHP condenses onto the load, [023]), but fails to teach wherein the low frequency pressure wave moves liquid hydrogen peroxide in contact with the sterilization load.
Herrig teaches wherein “the sterilant fluid 132 can be a room temperature (e.g., 20° C. to 25° C.) substance that can be dispersed as a fluid, such as a liquid, a vapor, or a combination thereof (such as a fog) during the decontamination process. Suitable substances for the sterilant fluid 132 include hydrogen peroxide” [0024], to which “the fluid oscillations created by the pressure pulse generator 136 produces movement of the sterilant fluid 132 within the decontamination chamber 104, which contains the sterilization load” ([0036]), in order to “agitate flow within the decontamination chamber” ([0009]) and increase exposure of the device to the sterilant fluid ([0020]).
Modified Shodder and Herrig are analogous references, both directed to sterilization/decontamination systems and methods.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to modify modified Shodder’s teaching of condensed VHP on the sterilization load by incorporating a pressure pulse generator moving sterilant fluid into the chamber as taught by Herrig in order to “agitate flow within the decontamination chamber” (Herrig, [0009]) and increase exposure of the device to the sterilant fluid (Herrig, [0020]).
Regarding claim 9, modified Shodder teaches sterilization load comprising the object to be sterilized and a package to hold the object (“a syringe may be packaged in a plastic 'blister' configured to house the syringe and restrict it from movement”, [019]) but fails to teach wherein the sterilization load includes a semi-permeable envelope.
Herrig teaches wherein the terminal package (118, Fig. 1, directed to a sterilization load) may be formed from “a flexible material such that the terminal package 118 has a flexible shape. Suitable materials for the terminal package 118 include but are not limited to a polymeric non-woven sheet, such as spun-bonded polyethylene (e.g., Tyvek®)” ([0032]).
Modified Shodder and Herrig are analogous references, both directed to sterilization/decontamination systems and methods.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to modify modified Shodder’s sterilization load having a package with the object to be sterilized by incorporating a semi-permeable package/envelope to hold the object to be sterilized as taught by Herrig instead for the benefit of flexibility (Herrig, [0032]).
Regarding claim 19, modified Shodder teaches wherein the sterilization chamber comprises a load (sterilization load having a package containing an object to be sterilized, [019]), and the load includes a semi-permeable material defining an interior of the load and an exterior of the load (“PFS may be sealed using a semi-permeable gas membrane 'lidding’”, [019]); and a plurality of third sterilization pulses (see claim 3, “between 2 and 5 sterilization pulses”), but fails to teach wherein after the plurality of third sterilization pulses, a concentration of hydrogen peroxide in the interior of the load is approximately equal to a concentration of hydrogen peroxide in the exterior of the load.
Herrig teaches wherein the sterilization chamber comprises a load (products 105, Fig. 1), and the load includes a Tyvek material defining an interior of the load and an exterior of the load (terminal package/container 118 housing device 120 to be decontaminated); and wherein after, a concentration of hydrogen peroxide in the interior of the load is approximately equal to a concentration of hydrogen peroxide in the exterior of the load (“the pores 122 may be sized so as to allow the sterilant fluid 132 and/or air to communicate into and out of the container 118 as well as prevent microbes from entering the terminal package 118”, see [0034] and Fig. 1).
Modified Shodder and Herrig are analogous references, both directed to sterilization/decontamination systems and methods.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to modify modified Shodder’s sterilization load having a package containing an object to be sterilized by incorporating a semi-permeable package/envelope with pores as taught by Herrig to allow for concentration equalization of hydrogen peroxide after the sterilization pulses (Herrig, [0034]).
The modified Shodder/Herring combination (see claim 18 rejection above) teaches executing an aeration pulse including: (i) lowering the pressure of the sterilization chamber to a first aeration pressure, wherein the first aeration pressure is less than 650 millibar (Shodder, step 322, Fig. 3B, and “the vacuum level may be, for example, between about 500 millibars and about 850 millibars, such as between about 500 millibars and about 800 millibars, between about 550 millibars and about 750 millibars, or between about 600 millibars and about 700 millibars”, [064]); and (ii) increasing the pressure of the sterilization chamber to a second aeration pressure, wherein the second aeration pressure is greater than 700 millibar (Shodder, step 326 and 328, Fig. 3B, and “air may be concurrently allowed to vent into sterilization chamber 102, such that the pressure in sterilization chamber 102 returns to, or near, atmospheric pressure”, [067]).
The modified Shodder/Herrig combination fails to teach wherein a rate of pressure change in step (ii) is at least 100 millibar per minute faster than a rate of pressure change in step (i).
Matsuo teaches an aeration step that is at least 100 millibar per minute faster than the depressurization in step (i): “in the aeration step S113 in this case, assuming that the time required for decompression is about 3 minutes and the time required for atmospheric injection is about 0.5 minutes” (see page 12, first paragraph of English translation, also in conjunction with Fig. 10 to obtain the pressure parameters to do the necessary calculations, which end up being greater than 100 millibar per minute).
Shodder, Herrig, and Matsuo are analogous references, all directed to sterilization systems for an object by utilizing hydrogen peroxide as the sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to combine the modified Shodder/Herrig combination of a sterilization system comprising aeration pulse steps with a pressure rate difference greater than 100 millibar per minute during pressurization than depressurization as taught by Matsuo because the combination of this feature would yield the predictable result of aerating the object to be free of sterilant through a series of aeration steps.
8. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shodder (WO 2018182929 A1) in view of Matsuo et al. (WO 2020183696 A1), further in view of Herrig et al. (US 20200330634 A1), as applied to claim 20 above, further in view of Karthaus et al. (U.S. Patent No. 5472667 A).
Regarding claim 21, Shodder in the Shodder/Herrig/Matsuo combination teaches prior to the aeration phase, removing moisture from the sterilization chamber (Shodder, step 342, Fig. 3C, and “achieving a vacuum level may promote removing of moisture from sterilization chamber 102 and thus the sterilization load. Thus, the sterilization load may be dried”, see [070]).
The Shodder/Herrig/Matsuo combination fails to teach removing moisture in the sterilization chamber by a condenser.
Karthaus teaches a condenser 50 (Fig. 1) hooked up to a sterilization chamber, removing moisture: “In a method and an apparatus for recovering a sterilizing gas, in particular ethylene oxide, materials to be sterilized are sterilized with the sterilizing gas in a sterilizing chamber; the sterilizing gas/air mixture withdrawn from the sterilizing chamber is predried in a precooler; the predried sterilizing gas/air mixture is freed from residual moisture in a drier, the sterilizing gas liquefied in a low-temperature condenser and stored in a storage container until reuse in the sterilizing chamber” (see Abstract).
Shodder, Herrig, Matsuo, and Karthaus are analogous references, all directed to sterilization systems for objects via a sterilant.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the effective filing date of the claimed invention to modify the Shodder/Herrig/Matsuo combination teaching of the removal of moisture prior to the aeration phase by incorporating a condenser as taught by Karthaus in order to collect and store moisture within the chamber (Karthaus, abstract).
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
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/Aham Lee/Examiner, Art Unit 1758
/SEAN E CONLEY/Primary Examiner, Art Unit 1799