DETAILED ACTION
This is the first action in response to US Patent Application No. 18/334,170, filed 13 June, 2023, with priority to provisional application 63/352,117, filed 14 June, 2022. All claims 1-20 are pending and have been fully considered.
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 .
Claim Interpretation
Claim 1 refers to a temperature “below room temperature” (lines 3-4). The specification suggests that room temperature encompasses a range of approximately 18-24 °C (page 4, line 21), with certain examples identifying 20°C (page 9, line 27; page 10, lines 5 and 15; page 6, line 3) or 21 °C (page 13, line 14) as room temperature values. The broadest range of room temperature set forth in the instant specification (18-24 °C) is adopted for purposes of examination. Accordingly, for a temperature to be “below room temperature”, the temperature must be less than 18°C.
Claims 15-16 define values or ranges with the term “about”. The term “about” is interpreted as defining a range within 10% of an associated recited value.
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.
Claims 17-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 17, the claim recites “a sterilization chamber for use in sterilizing a product using a sterilant obtained from a sterilant source under control of a vacuum source with the assistance of a blower for circulating air in the sterilization chamber” (lines 2-4). The phrasing of the limitation renders the claim unclear with respect to which of the recited structures are required structures of the claim. Particularly, the phrase “for use in” and “using” appear to be reciting an intended use of the sterilization chamber, such that a sterilant source is not necessarily a required structure of the claimed system. Furthermore, the limitation continues with “under control of a vacuum source”; it is not clear if the claim is indicating that the sterilant source is under control of the vacuum source, or if the sterilization chamber is under control of the vacuum source. If the claim is indicating the sterilant source is under control of the vacuum source, then the vacuum source would appear to be part of the recitation of an intended use and not is not necessarily a required structure of the claimed system. It is similarly ambiguous if the “assistance of a blower for circulating air in the sterilization chamber” is also part of the intended use recitation, or if the blower is a positively recited feature of the claim.
For purposes of examination, the sterilant source, vacuum source, and blower are interpreted as required structures of the claimed system. The claim language should be adjusted to positively recite the stated structures. An exemplary adjustment to the limitation of lines 2-4 is as follows: “a sterilization chamber configured for , wherein a sterilant source under control of a vacuum source and a blower configured for circulating air in the sterilization chamber provide the sterilant to the sterilization chamber.” Alternative clarifying amendments are appropriate.
Claims 18-20 are rejected by virtue of dependency on claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 17 is rejected under 35 U.S.C. 102(a)(1&2) as being anticipated by, Yoo (US 2013/0004380 A1, cited in the IDS filed 03 October, 2023).
Regarding claim 17, Yoo teaches a sterilization system (sterilizing apparatus—title) comprising:
A sterilization chamber (11) for use in sterilizing a product for use in sterilizing a product using a sterilant (hydrogen peroxide) obtained from a sterilant source (13/14) under control of a vacuum source (15) with the assistance of a blower (16) for circulating air in the sterilization chamber (sterilization apparatus 10 comprises a housing 12 with a sterilization chamber 11 filled with a to-be-sterilized object, an evaporator 13 and hydrogen peroxide supply apparatus 14 configured to supply hydrogen peroxide vapor to the sterilization chamber 11, a vacuum pump 15 configured toa adjust the internal pressure of the sterilization chamber 11, and a blower 16 configured to forcibly flow air in the interior of the chamber 11—[0063]; evaporator 13 evaporates hydrogen peroxide supplied by apparatus 13 by heating—[0068]; the pressure in the chamber is about 1 Torr or less when the hydrogen peroxide is supplied to the chamber—[0078]; blower 16 achieves heating—[0069],[0081])
A control and monitoring system (41) for controlling conditions in the sterilization chamber (controller 41—[0064], [0066]-[0068], [0073]; controller 41 serves to control the whole operations of the sterilization apparatus 10—Fig. 2, [0074]),
The control and monitoring system (41) configured to perform a method comprising:
Warming the product the sterilization chamber (quickly raising the temperature of the to-be-sterilized objects in the interior of the sterilization chamber by means of [convection] of warm wind using a fan and a heater—[0026]; fan heater 24 operated to heat the air in the sterilization chamber 11 and spread the heated air to the to-be-sterilized objects int eh chamber—[0076]; controller 41 understood to control this operation based at least on [0074] indicating the controller controls the whole operation of the apparatus and the operative connection between the controller 41 and fan heater 24 depicted in Fig. 2);
And sterilizing the product in the sterilization chamber using the sterilant source (hydrogen peroxide vapor supply adjusting valve 20 is open and the hydrogen peroxide vapor from the evaporator is supplied to the sterilization chamber and the objects to be sterilized—[0078]; sterilization is performed as the hydrogen peroxide vapor penetrates into the to-be-sterilized objects—[0079]; controller 41 controls valve 20, see Fig. 2 and [0076]).
See Figs. 1-2 of Yoo below.
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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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 2021/0261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1).
Regarding claim 1, Bitong teaches a method of sterilizing a product (external sterilization of drug delivery devices—title) outlined in Fig. 8 below.
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During the preconditioning step (4), products (syringes) are removed from storage (preconditioning includes some or all of the following steps: removing the samples from storage, allowing the syringes to adjust to room condition equilibration for a desired amount of time, and placing the syringes into a sterilization chamber. Preconditioning may occur inside or outside the chamber—[0044]), placed in a sterilization chamber, and allowed to equilibrate to room temperature (the syringes may be preconditioned inside of the sterilization chamber—[0045]). Thus, Bitong teaches steps of removing the product from storage; placing the product in a sterilization chamber; and equilibrating the temperature of the product in the sterilization chamber. Bitong further teaches sterilizing the product in the sterilization chamber (gas injection step 7 includes injecting a sterilization gas into the chamber and holding for a desired dwell time—[0047]).
Bitong does not explicitly indicate that the storage from which the product is removed is cold storage such that the product remains below room temperature when first placed in the chamber, and such that the equilibrating to room temperature causes warming of the product within the chamber. However, it is first noted that Bitong teaches that the product equilibrates to room temperature within the chamber ([0044]-[0045]), which indicates that the product is stored at and initially placed in the chamber at a temperature that is either above or below room temperature. Furthermore, the product of Bitong is a drug delivery device, such as a syringe, that is prefilled with a medicament (box 3 of Fig. 8 requires filling the barrel of a drug delivery syringe—[0043]; pre-filled syringe 50—[0030]; Fig. 6—[0019]; pre-filled form, wherein a set dosage or amount of medicament may be provided therein—[0003]), wherein the medicament can be substantially any drug (drug can refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics—[0079]; particular examples include: a VEGF antagonist [0081], colony stimulating factors [0082], proteins [0083], sclerostin antibody [0084]). It is well known that for many pharmaceutical products (i.e., medicaments), it is best practice to store the product at a temperature below room temperature to preserve the properties of the product and extend shelf life. This is evidenced at least by Weikart et al. (US 2020/0171244 A1) teaching a VEGF-antagonist—which is one of the medicaments explicitly contemplated by Bitong ([0081])—that is stable at a temperature of 2 to 8 °C for up to two years, but is less stable at temperatures at or above room temperature (VEGF antagonist is stable at a temperature of 2 to 8 °C most preferably for about two years…is stable at room temperature most preferably for at least three months…and is stable at a temperature of about 40°C for most preferably for one or two weeks—[0322]). It is thus evident that pharmaceutical products such as VEGF antagonist should preferably be stored at cool temperatures below room temperature (e.g., between 2 °C and 8 °C) to preserve the properties thereof and extend the shelf life of the pharmaceutical product.
Accordingly, it is fairly implied to a person having ordinary skill in the art that, at least for certain embodiments of Bitong (e.g., embodiments wherein the drug is a VEGF antagonist), the product is stored in cold storage below room temperature, is transferred to the chamber at a temperature below room temperature, and the product is warmed as it equilibrates to room temperature within the chamber. Also, it would otherwise be obvious to store the pharmaceutical product of Bitong in cold storage below room temperature [such that the pharmaceutical product is below room temperature when placed in the chamber and warmed while equilibrating in the chamber] for the benefit of storing the pharmaceutical product at a temperature at which it is most stable (Weikart at [0032] fairly indicates that VEGF antagonists are most stable at a temperature of 2 to 8 °C).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1), as applied to claim 1 above, and further in view of Yoo (US 2013/0004380 A1).
Regarding claim 2, Bitong evidenced by Weikart teaches the method of claim 1. Bitong and Weikart do not clearly teach the sterilization chamber includes an air circulation device, and the step of warming the product comprises activating the air circulation device.
However, in the analogous art of sterilization chambers (abstract), Yoo teaches a sterilization apparatus (10) comprising a housing (12) with a sterilization chamber (11) that receives objects to be sterilized by hydrogen peroxide vapor, the hydrogen peroxide vapor being injected into the chamber from an evaporator (13) ([Fig. 1, [0063]). The chamber further includes a blower (16) comprising a fan (34) ([0068]) and a fan heater (24) which heats air flowing through the fan in order to quickly heat the whole air in the sterilization chamber ([0071]). The heated air consequently heats the objects within the chamber by convection (quickly raise the temperatures of the to-be-sterilized objects in the interior of the sterilization chamber by means of the [convection] phenomenon of warm wind using a fan and a heater—[0026]; fan heater 24 heats air flowing through chamber which is then uniformly spread to the to-be-sterilized objects and within the sterilization chamber—[0076]). The heating of the object prevents condensation of the hydrogen peroxide vapor, improving sterilization performance by allowing better penetration of the hydrogen peroxide vapor into the object being sterilized (the hydrogen peroxide vapor does not condense, enhancing sterilizing performance—[0026]; hydrogen peroxide vapor condensation is prevented, so more hydrogen peroxide vapor can penetrate into the to-be-sterilized objects, thus enhancing the sterilization effects—[0081]).
Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Bitong such that the warming step includes include activating an air circulating device and heating air passing through the air circulation device, as seen in Yoo ([0076]), for the benefit of improving sterilization performance (Yoo at [0026] and [0081] explains how heating an object in a sterilization chamber by convection with a fan and fan heater prevents condensation of hydrogen peroxide vapor, which improves the penetration of the hydrogen peroxide sterilant into the object to be sterilized).
Regarding claim 3, the combination of Bitong, Weikart, and Yoo teaches the method of claim 2. As modified in view of Yoo with respect to claim 2, the method of Bitong further comprises warming air passing through the air circulation device (see rejection of claim 2 above; Yoo heats air passing through a fan 34 with a heater 24—[0076]—for the benefit of preventing condensation of the sterilant for improved sterilization performance—see [0026], [0081]). .
Regarding claim 4, Bitong evidenced by Weikart teaches the method of claim 1. Bitong and Weikart do not clearly teach the step of warming the product comprises warming the sterilization chamber wall.
However, Yoo teaches the sterilization apparatus (10) discussed with respect to claims 2-3 above, which further includes chamber heaters (25, 26) which assist in heating the air of the sterilization chamber (as the first sterilization chamber heater 25 and the second sterilization chamber heater 26 are operated along with the fan heater 24, the temperature of the sterilization chamber 11 can be more quickly raised—[0076]; also see [0072]), and consequently assist in heating the objects to be sterilized through convection (see Yoo at [0026]). Viewing Fig. 1 of Yoo, it is evident that the heaters (25, 26) are positioned to operate by heating the walls (18, 12) of the chamber (chamber heater engaged to the housing for the purpose of heating the housing and raising the internal temperature of the sterilization chamber—[0021]). Therefore, it would be obvious to a person having ordinary skill in the art to modify the device method of Bitong to include warming the sterilization chamber wall with a heater, as seen in Yoo, for the benefit of more rapidly increasing the air temperature within the sterilization chamber (Yoo at [0076]) which consequently heats the object to be sterilized and inhibits the undesirable condensation of sterilant thereupon (see Yoo at [0026], and [0081]).
Claim 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1), as applied to claim 1 above, and further in view of Young (4,457,892 A).
Regarding claim 5, Bitong in view of Weikart teaches the method of claim 1. Bitong and Weikart do not clearly teach the step of warming the product comprises cycling pressure, in a warming cycle, within the sterilization chamber between a first pressure and a second pressure, the second pressure being lower than the first pressure.
However, in the analogous art of sterilization with biocidal gas (title, abstract), Young teaches a chamber (10) which receives goods to be sterilized (column 2, lines 12-21) and in which the goods are exposed to a biocidal gas after a conditioning phase (column 2, lines 65-68). The conditioning phase includes evacuation (31) of the chamber to a sub atmospheric pressure, re-pressurization (34) of the chamber with steam, and repeating the evacuation and steam injection between a higher first pressure (36) and a lower second pressure (64) in order to raise the temperature and moisten the goods to a desired level (Figs. 1-2, column 2, lines 49-64). Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Bitong to include a step of warming the product by cycling between a higher first pressure and a lower second pressure, wherein steam is used in the re-pressurization step, as seen in Young, for the benefit of raising the temperature and the moisture of the product to a desired level (see Young at column 2, lines 49-64).
See the pressurization cycle within the conditioning portion of Fig. 2 of Young below.
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Regarding claim 6, the combination of Bitong, Weikart, and Young teaches the method of claim 5. As modified with respect to claim 5, the method of Bitong effectively incorporates the conditioning steps of Young (Fig. 2, see elements 31, 32, 34, 36, and 64; see column 2, lines 60-64). Young does not explicitly discuss the duration of the cycle steps of pressurizing, dwelling at the increased temperature, depressurizing, and dwelling at the decreased pressure. Nonetheless, the steps of pressurizing and depressurization steps clearly last for some duration of time (see Fig. 2, wherein, e.g., pressure is raised from 60 mmHg to 90 mmHg in within a few minutes). Also, although Fig. 2 does not depict extended dwelling at the first and second pressures, the time the system is at the first and second pressure much last for at least some duration of time (e.g., a few seconds, or fractions of a second), wherein such times fairly define dwell times as claimed. Accordingly, the pressurization cycle of Young—which is incorporated into the method of Bitong with respect to claim 5—must include reducing pressure over a first period of time from the first pressure (36) to the second pressure (32/64); dwelling at the second pressure (32/64) for a second period of time; increasing pressure over a third period of time from the second pressure (32/64) to the first pressure (36); and dwelling at the first pressure (36) for a fourth period of time (see Fig. 2 of Young).
Regarding claim 15, the combination of Bitong, Weikart, and Young teaches the method of claim 5. Bitong, Weikart, and Young do not teach the first pressure is about 100 kPa, and the second pressure is about 75 kPa (Young teaches a first pressure of 90 mmHg and a second pressure of 60 mmHg, see Fig. 2 at points 32 and 36). However, differences in pressure conditions do not support the patentability of subject matter unless there is evidence indicating such pressure is critical; see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) as cited in MPEP 2144.05. Furthermore, a person of ordinary skill in the art would recognize that a pressure of 100 kPa is approximately equal to atmospheric pressure, and that a sub-atmospheric pressure of 75 kPa is comparatively easy to achieve relative to the very low vacuum pressures of Young (60 mmHg). Accordingly, it would be obvious to a person having ordinary skill in the art to arrive at a first pressure of 100 kPa and a second pressure of 75 kPa by routine optimization of the pressure conditions of modified Bitong for the benefit of reducing the energy required for the pressure cycling (a pressure of about 100 kPa can be achieved by atmospheric venting, and a pressure of 75 kPa can be achieved by operating a vacuum pump for a shorter amount of time relative to a pressure approaching 0 kPa).
Regarding claim 16, the combination of Bitong, Weikart, and Young teaches the method of claim 5. Bitong, Weikart, and Young do not teach the first pressure is about 100 kPa, and the second pressure is about 50 kPa (Young teaches a first pressure of 90 mmHg and a second pressure of 60 mmHg, see Fig. 2 at points 32 and 36). However, for substantially the same reasons as discussed with respect to claim 14 above, it would be obvious to a person having ordinary skill in the art to arrive at a first pressure of 100 kPa and a second pressure of 50 kPa by routine optimization of the pressure conditions of modified Bitong for the benefit of reducing the energy required for the pressure cycling (a pressure of about 100 kPa can be achieved by atmospheric venting, and a pressure of 50 kPa can be achieved by operating a vacuum pump for a shorter amount of time relative to a pressure approaching 0 kPa).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1), as applied to claim 1 above, and further in view of Golkowski et al. (US 2019/0314535 A1).
Regarding claim 8, the combination of Bitong and Weikart teach the method of claim 1. Bitong teaches gas purge (8) and aeration (9) steps following the sterilization (7) step (Fig. 8), but does not clearly teach after sterilizing the product, cooling the product in the sterilization chamber. Weikart does not teach the claimed cooling.
However, in the analogous art of sterilization methods (title), Golkowski teaches a method of operating a sterilization system in three phases, wherein a first phase includes drying and heating items within a chamber (10) ([0287]-[0291]), a second phase includes sterilizing items within the chamber with a plasma generator and/or vaporizer ([0292]-[0294]), and a third post-sterilization phase includes additional warming and drying steps ([0295]-[0296]) followed by cooling ([0297]-[0298]: heater 26 is turned off with blower 16 and/or 14 remaining on so that fresh air is passed through he system for a sufficient time to cool down to the ambient temperature or until a desired temperature is reached). Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Bitong to include, after the sterilization step, a step of drying the and warming items in the chamber followed by a step of cooling the items, as seen in Golkowski ([0295-[0299]) for the benefit of removing moisture from the item and then returning the items to a desired temperature (Golkowski: continue cooling until a desired temperature is reached—[0298]; moist air expelled into atmosphere—[0295]).
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1) and in view of Golkowski et al. (US 2019/031435 A1), as applied to claim 8 above, and further in view of Ricciardi et al. (US 8,062,590).
Regarding claim 9, the combination of Bitong, Weikart, and Golkowski teaches the method of claim 8, wherein the step of cooling the product comprises cooling the sterilization chamber wall. As discussed with respect to claim 8 above, Golkowski suggest cooling an item within a sterilization chamber to a desired temperature following a sterilization step (see Golkowski at [0298] and rejection of claim 8 above). Bitong, Weikart, and Golkowski do not indicate that the cooling includes cooling the sterilization chamber wall.
However, Ricciardi teaches analogous methods for the sterilization of objects (abstract), wherein surfaces within the sterilization chamber can be cooled by various means (column 16, lines 64-67), including the application of chilled air (column 44, lines 38-50; surfaces within the secondary chamber can be cooled with refrigerated or chilled air before, during, or after the application of the applied agent—column 17, lines 25-28), which would be expected to have the effect of cooling the sterilization chamber wall. Therefore, it would be obvious to a person having ordinary skill in the art to cool the object within the sterilization chamber to a desired temperature—as suggested by Golkowski ([0298])—by applying chilled air into the sterilization chamber (as seen in Golkowski), which would have the effect of cooling the sterilization chamber walls. Such modification amounts to the ordinary application of one cooling technique (applying chilled air) to a known method (method of Bitong) for the expected benefit of facilitating the cooling of a product within the chamber to a desired temperature; see MPEP 2143(D.) regarding the obviousness of applying a known technique to a known device to yield predictable results.
Regarding claim 13, the combination of Bitong, Weikart, and Golkowski teaches the method of claim 8. As discussed with respect to claim 8 above, Golkowski suggests modifying Bitong to include a step of cooling an object to a desired temperature while the object is in a sterilization chamber and after the object has been sterilized. Golkowski further suggest that the cooling is facilitated by activation of an air circulation device (blowers 14 and 16 remain on –[0297]—during cooling—[0298]). Golkowski does not indicate that the air is cooled; Bitong and Weikart also do not clearly suggest cooling air passing through an air circulation device. However, as discussed with respect to claim 9 above, Ricciardi suggest cooling an object within a sterilization chamber by applying cooled air into the chamber (column 44, lines 38-50; column 17, lines 25-28). Accordingly, it would be obvious to apply chilled air to the chamber of the modified system of Bitong because such modification amounts to applying a known cooling technique (applying chilled air) to a known system (system of Bitong) for the expected benefit of facilitating the cooling of a product within the chamber to a desired temperature. Furthermore, it would be obvious to facilitate the application of the chilled air by operation of an air circulation device for the benefit of increasing the rate of cooling by convective heat transfer.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1) and in view of Golkowski et al. (US 2019/031435 A1), as applied to claim 8 above, and further in view of Shodder (US 2022/0331470 A1, filed 30 March, 2022).
Regarding claim 10, the combination of Bitong, Weikart, and Golkowski teaches the method of claim 8. As discussed with respect to claim 8, Golkowski fairly suggests modifying the system of Bitong to include a step of cooling an object within the sterilization chamber following sterilization of the object. Bitong, Weikart, and Golkowski do not suggest that the cooling step includes cycling pressure for cooling in the sterilization chamber between a third pressure and a fourth pressure, the fourth pressure being less than the third pressure.
However, in the analogous art of sterilization methods using vaporized chemicals (title, abstract), Shodder teaches sterilization methods wherein a sterilization load is loaded into a sterilization chamber, and then preconditioning, sterilization, and aeration phases are carried out within the chamber ([0147], [0151]). Figs. 8A and 9A of Shodder depict the chamber pressure and temperature as a function of time over the course of the sterilization method. In both Figs. 8A and 9A, it is clear that the second aeration phase achieves cooling (a decrease in temperature) while the chamber pressure is cycled between a higher pressure (over 1000 mbar) and a lower pressure (550 mbar). See exemplary Fig. 8A below.
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Therefore, it would be obvious to a person having ordinary skill in the art to adopt the cooling step of Shodder (seen in the final aeration phase of Figs. 8A-B or 9A-B) wherein the chamber pressure is cycled between a higher third pressure and a lower fourth pressure for the benefit of cooling the product within the chamber to a desired temperature.
Regarding claim 11, the combination of Bitong, Weikart, Golkowski, and Shodder teaches the method of claim 10. As modified with respect to claim 10, the method of Bitong incorporates the pressure cycling cooling step of Shodder. Viewing, e.g., Figs. 8A-B and 9A-B of Shodder, it is clear that the pressure cycling includes reducing pressure over a fifth period of time from the third pressure to the fourth pressure (Figures show decrease from about 1000 mbar to about 500 mbar over a duration of time); dwelling at the fourth pressure for a sixth period of time (the pressure is at the low pressure of about 500 mbar for at least a moment, said moment having a duration defining a sixth period of time); increasing pressure over a seventh period of time from the fourth pressure to the third pressure (Figures show an increase from the pressure of about 500 mbar to the pressure of about 1000 mbar); and dwelling at the third pressure for an eighth period of time (the Figures show the pressure sustained at 1000 mbar between the increasing and decreasing steps of the cycle).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bitong et al. (US 20210261297 A1) evidenced by Weikart et al. (US 2020/0171244 A1), and in view of Young (4,457,892 A), as applied to claim 5 above, and further in view of Joslyn (US 4759909 A).
Regarding claim 14, the combination of Bitong, Weikart, and Young teach the method of claim 5. Bitong and Weikart do not teach pressure cycling. As discussed with respect to claim 5 above, Young does teach pressure cycling, but the first and second pressure are both below atmospheric pressure (see Fig. 2: first pressure 36 is about 90 mmHg, and second pressure 32 is about 60 mm Hg).
However, in the analogous art of sterilization systems including chambers (title, abstract), Joslyn teaches operations of a sterilization system including a conditioning phase (119) wherein steam injection and atmospheric venting are performed cyclically to cycle between a higher first pressure (point 104 at Fig. 2) and an ambient second pressure (point 106 in Fig. 2) in order to heat the object to be treated and displace air inside of the system (Fig. 2, column 4, line 60, through column 5, line 30). Therefore, it would be obvious to a person having ordinary skill in the art to further modify the method of Bitong such that the pressure cycling is between a first pressure above atmospheric (i.e., ambient) pressure and a second pressure that is equal to atmospheric pressure, as seen in Joslyn (Fig. 2), for the benefit of maintaining the result of heating the object to be sterilized to a desired temperature (steam heats the portions of the load—column 5, lines 9-11).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo (US 2013/0004380 A1) in view of Young (US 4457892 A).
Regarding claim 18, Yoo the system of claim 17. Yoo does not clearly teach that the control and monitoring system is configured to perform the step of warming the product by using the vacuum source to cycle pressure within the sterilization chamber between a first pressure and a second pressure, the second pressure being lower than the first pressure.
However, as discussed with respect to claim 5 above, Young teaches a chamber (10) which receives goods to be sterilized (column 2, lines 12-21) and in which the goods are exposed to a biocidal gas after a conditioning phase (column 2, lines 65-68). The conditioning phase includes evacuation (31) of the chamber to a sub atmospheric pressure, re-pressurization (34) of the chamber with steam, and repeating the evacuation and steam injection between a higher first pressure (36) and a lower second pressure (64) in order to raise the temperature and moisten the goods to a desired level (Figs. 1-2, column 2, lines 49-64). Therefore, it would be obvious to a person having ordinary skill in the art to modify the system of Yoo such that the controller is configured to perform a step of warming the product by cycling between a higher first pressure and a second pressure, wherein the depressurization is accomplished by the operation of a vacuum pump and the re-pressurization is accomplished by injection of steam, as seen in Young, for the benefit of raising the temperature and the moisture of the product to a desired level (see Young at column 2, lines 49-64).
Regarding claim 20, Yoo in view of Young teaches the system of claim 18. As substantially discussed with respect to claim 4 above, Yoo teaches the controller is configured to perform a step of warming the product by warming the sterilization chamber wall (chamber heaters 25, 26 operate to heat chamber hosing 12 and door 18 to assist in rapidly raising the temperature of the air inside the chamber 11, and consequently raising the temperatures of objects to be sterilized within the chamber—see Figs. 1-2, [0021], [0026], [0072], and [0076]). As modified in view of Young with respect to claim 18 above, the system of Yoo is further configured to warm the product in the chamber by cycling between a first and second pressure (see rejection of claim 18 above). It would be obvious to a person having ordinary skill in the art to try combining the product warming techniques of wall heating and pressure cycling such that they occur simultaneously for the benefit of more rapidly warming the product to the desired temperature (Yoo at [0076]: as the first sterilization chamber heater 25 and the second sterilization chamber heater 26 are operated along with the fan heater 24, the temperature of the sterilization chamber 11 can be more quickly raised).
Allowable Subject Matter
Claim 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 19, Yoo in view of Young teaches the system of claim 18. Yoo and Young do not teach the control and monitoring system being configured to perform the step of warming the product by performing steps of: using the vacuum source to reduce pressure over a first period of time from the first pressure to the second pressure; dwelling at the second pressure for a second period of time; allowing gas to enter the sterilization chamber to increase pressure over a third period of time from the second pressure to the first pressure; and dwelling at the first pressure for a fourth period of time; wherein the first period of time is longer than the third period of time.
As understood in view of the specification and an ordinary level of skill in the art, it is understood that the claimed pressure cycle is defined by a more abrupt compression stage (corresponding to the third period of time) and a longer decompression stage (corresponding to the third period of time). The abrupt compression stage roughly approximates an adiabatic heating step, wherein the increase in pressure causes the gasses inside the chamber to increase in temperature. The prolonged decompression roughly approximates isothermal decompression, so that the temperature inside the chamber is not significantly decreased as the pressure is decreased. Repeating the abrupt compression and gradual decompression results in a net warming effect. Although adiabatic heating and isothermal decompression are well established concepts, no prior art was found which fairly suggests applying a pressure cycle including a quicker compression step and a slower decompression step to a sterilization chamber in order to achieve the effect of warming a product within the chamber. Accordingly, the subject matter of claim 19 is novel and non-obvious over the prior art.
Claims 7 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 7, the subject matter of claim 7 corresponds to the subject matter of claim 19, and is allowable for similar reasons. Particularly, although Bitong et al. (US 20210261297 A1), Weikart et al. (US 2020/0171244 A1), and Young (4,457,892 A) suggest the method of claim 6, no reference was found which particularly suggest reducing pressure over a first period of time from the first pressure to the second pressure; dwelling at the second pressure for a second period of time; increasing pressure over a third period of time from the second pressure to the first pressure; and dwelling at the first pressure for a fourth period of time, wherein the first period of time is longer than the third period of time.
Regarding claim 12, the combination of Bitong, Weikart, Golkowski, and Shodder teaches the method of claim 11. The stated combination does not clearly teach that the firth period of time is shorter than the seventh period of time. The limitation is understood to be significant because it is directed toward a cycle comprising more rapid decompression steps combined with more prolonged compression steps. The abrupt decompression roughly approximates adiabatic cooling, whereas the prolonged compression approximates isothermal compression; as a result the cycle has the net effect of reducing the temperature within the chamber. No prior art was found which fairly suggests the claimed sequence of steps in a pressure cycle as part of a cooling step, in combination with the further steps of the claim. Accordingly, the subject matter of claim 12 is novel and non-obvious over the prior art.
Conclusion
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797