Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/7/2026 has been entered.
Response to Amendment/Arguments
The Amendment filed 4/7/2026 has been entered. Claims 1, 3-7, 10-16, and 18-23 remain pending on the application. Claims 6, 7, 10, 11, 16, and 18-20 were previously withdrawn.
Applicant argues that the new claim amendments overcome the rejections of record.
Regarding the amendment reciting a flat cover side for the cover unit, this does not change what is claimed in the structure of the apparatus and is read upon by the secondary reference, Gordon, which as a flat cover side. In addition, the prior art can read on the recited gap between the cover plate and the lidding foil depending on the height of the receptables, since the receptacles are not positively recited in claim 1. The other amendment regarding the device being configured to produce a laminar flow of gas is read upon by the prior art since the device of Frost can be operated under conditions which allow for a laminar flow because Frost can control for pressure, temperature, and concentration of hydrogen peroxide (which in turn determines fluid density, which is used to calculate the Reynold’s number, which in turn determines whether or not the flow is laminar or turbulent). The amendment also recites return air ducts arranged to the side of the cover unit. Frost already has a return air duct that is interpreted to be located on a front side of the cover unit modified onto it. Therefore, claim 1 remains rejected. No amendments have been made to the dependent claims so they remain rejected as well.
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. 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a decontamination unit” in claim 1 and “a circulation device” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. “a decontamination device” is interpreted in light of Specification par. 17 to be an evaporation or nebulization device. These are known to one of ordinary skill in the art to be an evaporator or nebulizer, which have a sufficiently defined structure.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 14-15, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Frost (US 20040228759 A1, provided in Applicant’s IDS of 1/19/2024) in view of Duffey (US 5114670 A, provided in Applicant’s IDS of 8/3/2022) and Gordon (US 20130078142 A).
Regarding claim 1, Frost teaches a sterilizing device defining a space and configured for sterilizing an outer face of a receptacle positioned within the space, the device comprising a transfer lock (par. 24: For this purpose, a sterilization chamber 11, designed as a lock, is provided, in which solely the outer sides 10 of the transport containers 1 are sterilized again after the surrounding packaging 2 has been removed),
wherein the receptacle to be sterilized has a gas-permeable lidding foil (par. 23: The plastic tub 3 is sealed on its upper side with a bacteria-impermeable but gas-permeable foil-type cover 7)
and a gas-impermeable receptacle body (par. 5: This gas penetrates during sterilization through the surrounding packaging and also through the cover of the plastic tubs into the interior of the tubs and sterilizes hereby all surfaces within the packaging; NOTE: this does not include the tub body besides the cover)
which delimits a receiving space (Fig. 1: insider of tub 3))
which is accessible via a removal opening in the receptacle body, wherein the removal opening (29) is closed by the lidding foil (Fig. 1: portion covered by foil 7), wherein the transfer lock (12) also comprises a decontamination unit configured to generate a H2O2-containing atmosphere in the space (18) (par. 28: A watery solution comprising a suitable concentration of hydrogen peroxide is fed via a conduit 17 and via a feed valve 18 in feed direction G to the evaporator 16),
wherein the sterilizing device (10) is configured such that the H2O2-containing atmosphere (20) flows past the receptable (22) in a laminar flow from a side of the cover unit (14) (NOTE: this is dependent on the operating conditions, such as pressure, temperature, and fluid density, which can be controlled by the device of Frost and thus Frost is capable of performing this function; par. 19: Insofar as the actual process of repeated sterilization is carried out, it is in principal sufficient when the removal of the condensate layer in the previous sterilization process by means of evacuation of the sterilization chamber takes place at a pressure level which lies below the steam pressure of the water at the given temperature of the sterilization chamber, for example up to 70 mb in the case of an exemplary temperature in the sterilization chamber of 40.degree. C. In order to reduce the amount of any hydrogen peroxide which may have penetrated into the tubs, it is however more advantageous to evacuate at below the steam pressure of the applied watery hydrogen peroxide solution at the given temperature in the sterilization chamber, in the case of the named example that is--at a given concentration of the flowing-in vapour mix of 50 per cent in weight--at below 42 mb), and
wherein, on a side of the receptacle (22) arranged opposite the cover unit (14), the method includes carrying away the H2O2-containing atmosphere (20) from the receptacle (22) via a return air duct (42) arranged to the side of the cover unit (14) or via a plurality of return air ducts (42) arranged to the side of the cover unit (14) (Fig. 2: return line gated by valve 15, which is located on a side facing the ceiling, which is later modified to contain the cover unit).
but does not teach
wherein the transfer lock comprises a cover unit having a radiation source, the cover unit (14) including a flat cover side comprising a cover plate (36), the cover unit (14) extending into the space (18) to define a gap between the cover plate (36) and the lidding foil (26), and wherein the cover unit (14) is arranged relative to the receptacle such that the cover unit covers a region of the receptacle formed by the lidding foil and is configured to irradiate the lidding foil with electromagnetic radiation
wherein the cover plate is permeable to the radiation from the radiation source.
Duffey teaches a sterilization chamber utilizing both hydrogen peroxide and UV light sterilization (abstract: A process is disclosed for sterilizing surfaces utilizing hydrogen peroxide gas in combination with preselected ultraviolet energy). Duffey teaches wherein combining UV light sterilization with hydrogen peroxide sterilization will increase sterilization effectiveness (C2L15-18: The combination of the ultraviolet energy and the hydrogen peroxide vapor provides a synergistic effect for purposes of sterilizing and disinfecting the article to be sterilized). Duffey further teaches having UV light sources placed above, and thus covering, the items to be sterilized (Fig.: UV lamps 30)
Gordon teaches a UV sterilization container (An object is sterilized with ultraviolet-C (UV-C) radiation having a wavelength from about 235 nm to about 295 nm. An advantageous wavelength for the UV-C radiation is about 253.7 nm. The object is inserted into a container, which is then sealed). Gordon teaches wherein a series of UV lights cover the ceiling of the sterilization space, and wherein the UV lights have a bottom cover that is flat and transparent to UV radiation in order to protect the UV lights (Fig.1A: UV-C tube sources 134, partition 120; par. 35: The partition 120 and the partition 122 are fabricated from material, or materials, substantially transparent to UV-C radiation; suitable materials are discussed below. The partition 120 and the partition 122 can be fabricated from the same material or from different materials. The partition 120 and the partition 122 can have the same thickness (measured along the Y-axis) or different thicknesses. The partition 120 prevents contact with the UV-C source 130).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Frost to have a series of UV lights located on the ceiling of the chamber, with a bottom transparent cover positioned over the items to be sterilized, as taught by Duffey and Gordon, in order to enhance sterilization effectiveness while protecting the UV light sources.
Frost modified by Duffey and Gordon teaches wherein the cover plate (36) and the lidding foil (26) are at a distance (39) from one another of less than 2 cm, thereby suppressing the H2O2-containing atmosphere within the space (18) from entering into the gap (NOTE: this depends on the type of receptacle, since a taller receptable would lead to a narrower gap, which then leads to the intended suppression effect).
Regarding claim 3, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and teaches wherein the radiation source is a UV radiation source (see Gordon modification in claim 1 rejection).
Regarding claim 4, Frost modified by Duffey and Gordon the sterilizing device (10) according to claim 1, as set forth above, and teaches wherein the decontamination unit (15) in the transfer lock (12) is designed to form a directed, low-turbulence gas flow (NOTE: this is dependent on the operating conditions, such as pressure, temperature, and fluid density, which can be controlled by the device of Frost and thus Frost is capable of performing this function; par. 19: Insofar as the actual process of repeated sterilization is carried out, it is in principal sufficient when the removal of the condensate layer in the previous sterilization process by means of evacuation of the sterilization chamber takes place at a pressure level which lies below the steam pressure of the water at the given temperature of the sterilization chamber, for example up to 70 mb in the case of an exemplary temperature in the sterilization chamber of 40.degree. C. In order to reduce the amount of any hydrogen peroxide which may have penetrated into the tubs, it is however more advantageous to evacuate at below the steam pressure of the applied watery hydrogen peroxide solution at the given temperature in the sterilization chamber, in the case of the named example that is--at a given concentration of the flowing-in vapour mix of 50 per cent in weight--at below 42 mb).
Regarding claim 5, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and teaches wherein the decontamination unit for generating the H2O2-containing atmosphere H2O2 in the transfer lock is designed to introduce H2O2 in a gaseous state or as a mist (par. 5: This gas penetrates during sterilization through the surrounding packaging).
Regarding claim 14, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and teaches wherein the electromagnetic radiation is high-energy light radiation generated by the radiation source (see Duffey modification for UV lights in claim 1 rejection; absent a recitation of a specific standard for what constitutes “high-energy” light, the light from the UV lights would have a finite energy that would read on “high-energy”).
Regarding claim 15, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 14, as set forth above, and teaches wherein the high-energy light radiation is UV radiation (see Duffey modification for UV lights in claim 1 rejection.
Regarding claim 21, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and is capable of a state wherein the distance (39) is less than 1.5 cm (NOTE: this depends on the type of receptacle, since a taller receptable would lead to a narrower gap.).
Regarding claim 22, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and is capable of a state wherein the distance (39) is less than 1 cm (NOTE: this depends on the type of receptacle, since a taller receptable would lead to a narrower gap, which then leads to the intended suppression effect).
Regarding claim 23, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, and is capable of a state wherein the distance (39) is less than 0.5 cm (NOTE: this depends on the type of receptacle, since a taller receptable would lead to a narrower gap, which then leads to the intended suppression effect).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Frost modified by Duffey and Gordon in view of Kleinman (DE 102017118481 A1) and Krainiak (US 5711705 A).
Regarding claim 12, Frost modified by Duffey and Gordon teaches the sterilizing device (10) according to claim 1, as set forth above, but does not teach further comprising a removal region, and wherein, in an initial state, the receptacle (22) is initially arranged in outer packaging, wherein, within the removal region, a cleaned gas is flushed around the receptacle (22) while it is being removed from the outer packaging in the removal region.
Frost already teaches removing the packaging prior to the tub being sterilized but does not teach a structure for doing so (claim 2: A process for a contamination-free insertion of already sterilized syringes into a filling apparatus surrounded by a sterile clean room for filling and sealing the syringes, comprising the steps of: providing sterile transport containers containing the syringes with a bacteria-impermeable and gas-permeable cover and a sealed bacteria-impermeable and gas-permeable additional packaging; releasing the transport containers from their additional packaging; sterilizing the outer side of the covered transport chambers in an evacuable sterilization chamber).
Kleinman teaches a sterilization chamber using hydrogen peroxide for sterilizing packaged goods (abstract: The invention relates to a decontamination device (1) for decontaminating products in the form of consumer goods and / or consumer packaging; pg. 2 par. 6: very particularly preferably to a hydrogen peroxide vapor). Kleinman teaches a chamber disposed upstream of the decontamination chamber capable of recirculating air (Fig.: product lock 22; pg. 8 par. 1: the decontamination agent concentration in the product lock 22 is reduced to a safe level for an operator, in this case by conveying room air through a corresponding catalyst in recirculation mode) and wherein product locks may be used for removing packaging (pg. 5 par. 2: In the product lock, unpacking means are preferably arranged for the automated unpacking of consumer goods from an outer packaging). Kleinman provides the motivation to have a chamber upstream of the sterilization chamber of Frost to fulfill Frost’s need for an unpackaging station, wherein that chamber is also capable of recirculating air.
Krainiak teaches an isolation chamber capable of circulating sterile, laminar air flow and also capable of allowing a user to remove the packaging from an article (abstract: An isolation work station comprising an enclosure, and an air circulation system and high efficiency air filter for generating a downwardly directed laminar air flow through the enclosure; C2L9-13: At least one flexible glove is sealably mounted in the front side wall of the enclosure, which is transparent, so as to permit a technician to reach through the front side wall and into the enclosure to perform work tasks therein and while being isolated from the environment within the enclosure).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Frost modified by Duffey and Gordon to have an isolation chamber disposed upstream of the sterilization chamber, capable of producing a sterile, laminar air flow within the chamber via an air circulation system, and having a mounted glove to allow a user to remove the packaging from an article, as taught by Kleinman and Krainiak, in order to provide a structure to remove the packaging from an article while keeping that article sterile, prior to sterilization. Frost modified by Duffey, Gordon, Kleinman, and Krainiak in this way is capable of performing the recited function.
Regarding claim 13, Frost modified by Duffey, Gordon, Kleinman, and Krainiak teaches the sterilizing device (10) according to claim 1, as set forth above, and teaches wherein a directed, low-turbulence gas flow is formed in the removal region is designed (see Krainiak modification in claim 12 rejection).
Conclusion
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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