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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/15/2026 has been entered.
Response to Amendment/Arguments
The Amendment filed 1/15/2026 has been entered. Claims 1-20 remain pending on the application. Claims 2, 10, 12, 15, and 19-20 have been withdrawn, pursuant to Applicant’s election without traverse filed 2/23/2025. Applicant’s amendment to the claims has overcome the objection to claim 1 set forth in the previous Office Action filed 8/27/2025.
Applicant argues that the new claim amendments overcome the rejections of record.
Examiner finds these arguments persuasive as directed to claims 1 and 3-7, for reasons elaborated below. However, the rejections to claims 8-9, 11, 13-14, and 16-18 have been updated to read on the new claim limitations. In particular, the rejections to claims 8-9, 11, and 13 rely on new prior art, Markesberry.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 recites the limitation "carrier" in the second to last line. There is insufficient antecedent basis for this limitation in the claim. Claims 3-7 are rejected as being dependent on claim 1. Should the Applicant overcome the noted rejection above in claim 1, then the rejections to claims 3-7 will be overcome as well.
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 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Markesberry (WO 2019075176 A2) in view of Andersson (WO 2008111893 A1).
Regarding claim 8, Markesberry teaches A method for sterilizing at least one workpiece item that is not a container (par. 15: In some embodiments, the methods of the present invention can be utilized to disinfect both porous and non-porous surfaces commonly found in the volumetric spaces listed above, including building walls, floors, ceilings, furniture, instruments, and electronics), comprising:
providing a sterilization chamber configured for hydrogen peroxide sterilization and a UV light source configured to illuminate the interior of said sterilization chamber (abstract: A method for disinfecting surfaces within a volumetric space; par. 42: In yet further embodiments, the peroxide compound is hydrogen peroxide. In still yet further embodiments, hydrogen peroxide is dispersed within the first aqueous composition.; par. 217: In a further embodiment of the invention, any of the above-described methods may further include the step of illuminating the surface to be disinfected with a wavelength consisting essentially of ultraviolet (UV) light);
contacting the at least one workpiece item with hydrogen peroxide (par. 42: In yet further embodiments, the peroxide compound is hydrogen peroxide. In still yet further embodiments, hydrogen peroxide is dispersed within the first aqueous composition.);
leaving remnant hydrogen peroxide on the at least one workpiece item; and illuminating the at least one workpiece item with UV light, wherein said illuminating decomposes said remnant hydrogen peroxide on the at least one workpiece item (par. 217: In a further embodiment of the invention, any of the above-described methods may further include the step of illuminating the surface to be disinfected with a wavelength consisting essentially of ultraviolet (UV) light… In addition to having its own biocidal activity, UV light can activate peroxide compounds to make them even more reactive in reactions with organic acid compounds to form peracids. For example, hydrogen peroxide can be activated when it is bombarded by intense UV light to form two hydroxyl radicals. In preferred embodiments, once an aqueous composition including a peroxide compound has deposited and coalesced upon a surface to be disinfected, the surface is then illuminated with a wavelength consisting essentially of UV light), but does not teach
loading the at least one workpiece item into said sterilization chamber
separating the at least one workpiece item from said hydrogen peroxide.
Andersson teaches a container sterilization apparatus (abstract: The invention relates to a method of producing a packaging container with low microbiological load by treating the packaging material with a combination of a chemical sterilization agent and UV-light).
Andersson teaches a method and structure that specializes in automating the hydrogen peroxide and UV sterilization process described by Markesberry, albeit for a smaller item, whereas Markesberry does not teach a more specific method and structure for sterilization within a general volumetric space. Therefore, Andersson provides a means to implement the method of Markesberry for one of the uses taught by Markesberry, such as a medical instrument (par. 120: The term "instrument" refers to the various medical or dental instruments or devices that can benefit from cleaning with a composition according to the present invention).
Specifically, Andersson teaches
loading the at least one workpiece item into said sterilization chamber (pg. 7 lines 25-26: The machine is also provided with means for conveying the packaging container blank into the sterile chamber);
separating the at least one workpiece item from said hydrogen peroxide (pg. 12 lines 3-8: After the chemical sterilization agent has been applied in station F, the packaging, container blank 7 is displaced to a subsequent station which carries reference designation G. There, the inside of the blank is exposed to irradiation sterilization. The irradiation preferably takes place with UV-light irradiation means in the form of a lamp 18 for UV-light which extends wholly or partly down into the packaging container blank) as well as preconditioning (abstract: The invention is characterised in that a first partial quantity of the chemical sterilization agent is applied on the packaging material a sufficiently long time; Fig. 1: station B) and aeration (pg. 12 lines 13-17: Once the actual microorganism-reducing treatment has been completed, the packaging container blank is displaced to a subsequent station H in which sterile, filtered hot air at a temperature of approx. 200°C is aspirated via an air pipe 20 down into the packaging container blank in order to flush clean the blank from residues of sterilization agent.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Markesberry to load a sterilization target into the volumetric space, precondition the target with hydrogen peroxide for a period of time, remove the target from the hydrogen peroxide environment/station to a UV sterilization station and to aerate the target afterwards, as taught by Andersson, in order to implement its sterilization method specifically for smaller objects such as medical instruments.
Regarding claim 13, Markesberry modified by Andersson teaches the method of claim 8, as set forth above, and teaches wherein the at least one workpiece item is at least one medical device (par. 120: The term "instrument" refers to the various medical or dental instruments or devices that can benefit from cleaning with a composition according to the present invention).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Markesberry modified by Andersson in view of Py (AU 2013245750 A1).
Regarding claim 9, Markesberry modified by Andersson teaches the method of claim 8, as set forth above, but is silent with regards to wherein said illuminating comprises illuminating the at least one workpiece item with pulsed UV light.
Py teaches wherein pulsed UV light provides the advantage of quick and effective sterilization (par. 59: The use of pulsed UV light allows for quick and effective sterilization of the device 12 as it moves from one workstation to the next).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the UV light source of Andersson to be a pulsed UV light source, as taught by Py, in order to provide quick and effective sterilization for items on a transport path.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Markesberry modified by Andersson in view of Stefl (WO 2022155281 A1).
Regarding claim 11, Markesberry modified by Andersson teaches the method of claim 8, as set forth above, and teaches wherein said contacting comprises contacting the at least one workpiece item with vapor phase hydrogen peroxide using a three stage process of preconditioning (see Andersson modification in claim 8 rejection), sterilization (par. 42: In yet further embodiments, the peroxide compound is hydrogen peroxide. In still yet further embodiments, hydrogen peroxide is dispersed within the first aqueous composition), and aeration (see Andersson modification in claim 8 rejection); but does not teach and wherein said illuminating is performed during said aeration.
Stefl teaches a sterilization and drying chamber using UV light (abstract: Systems and methods for treating an object, in particular, for disinfecting and/or drying objects and/or surfaces are provided. One or more of an air delivery system, an electromagnetic emitter (e.g., a Far ultraviolet (UV) light source), and/or an air treatment device (e.g., a gaseous hydrogen-peroxide generator) may be used to condition ambient air to treat a surface or container for use (e.g., prior to filling the container, applying a surfactant, etc.)). Stefl teaches illuminating UV light while the drying/aeration is performed because then the UV light can also sterilize the air that is used to dry the item (par. 13: The present disclosure is directed to systems and methods for treating an object, in particular, for disinfecting and/or drying containers and/or conveyance assemblies. One or more of an air delivery system, an electromagnetic emitter (e.g., a Far ultraviolet (UV) light source), and/or an air treatment device (e.g., a gaseous hydrogen-peroxide (H2O2) generator) may be used to condition ambient air to treat a surface or container for use (e.g., prior to filling the container, applying a surfactant, etc.); par. 5: The combined systems provide one or more of drying, blowing, air-rinsing, and disinfecting of the objects and/or surfaces concurrently). This also provides the advantage of saving time, making for a more efficient sterilization process.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the illumination step of Markesberry modified by Andersson to take place concurrently with an aeration step, as taught by Stefl, so that the air used to dry the item is also sterilized, and to save time, which makes for a more efficient sterilization process.
Claims 14, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson in view of Py.
Regarding claim 14, Andersson teaches A method for sterilizing at least one workpiece (abstract: packaging container), comprising:
exposing the at least one workpiece to a hydrogen peroxide environment for an exposure time of sufficient duration to sterilize the at least one workpiece (Fig. 1: station G, means 23 or alternately, spraying device 3; pg. 11 lines 28-29: by partly shown means 23 which is able to vaporise hydrogen peroxide and spray it onto the packaging material; pg. 5 lines 12-17: Yet a further currently preferred embodiment of the method according to the invention is characterised in that the application of said first partial quantity of the chemical sterilization agent takes place in the very first, or one of the first, stations in which the packaging material is treated when it is conveyed through the filling machine. By such means, the previously described exposure time is maximised most simply; NOTE: also, absent a specific recitation of an exposure time, the exposure time of the method of Andersson is a finite amount, which would read on a sufficient exposure time.);
separating the at least one workpiece from said hydrogen peroxide environment (Fig. 1: moving the item to station G after station F, or alternately, moving the item from station B to station C) leaving remnant hydrogen peroxide on and in the at least one workpiece PCCS (NOTE: there is no mentioned step of removing the hydrogen peroxide, so it is interpreted to remain on the item as it is illuminated with UV light; furthermore, illuminating the hydrogen peroxide with UV light would have the effect of decomposing it) ; and
illuminating the at least one workpiece with ultraviolet light (Fig. 1: station G with UV lamp 18) but does not teach wherein the workpiece item is a PCCS.
Py teaches wherein its method can be used for consumer products such as beverages OR parenteral products such as medicaments and vaccines (par. 44: The aseptic or sterile filling apparatus 10 is used to fill devices 12 such as containers or delivery devices for storing and dispensing liquid products, such as beverages, food, or nutritional products, vials or syringes for containing and/or dispensing any of numerous different types of products or substances, such as medicaments, vaccines, pharmaceuticals, dermatological products, ophthalmic products, and nutritional supplements). Andersson already teaches general containers capable of containing parenteral products since thermoplastic, liquid-tight materials would be capable of doing so. In addition, Andersson’s method presents an improvement upon that of Py’s in that it employs hydrogen peroxide sterilization in combination with UV sterilization for increased sterilization effectiveness, so there is motivation to apply the method of Andersson to sterilizing containers that are then filled with parenteral products.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Andersson to fill the containers with a parenteral product, as taught by Py, in order to provide effective sterilization for parenteral product containers that improves upon previous sterilization methods.
Andersson modified by Py is silent with regards to whether or not all of the hydrogen peroxide is decomposed.
However, a mere change in proportion, even if it leads to better results, holds no patentable significance:
MPEP 2144.05.II.A: Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
especially if it can be shown that the change in proportions can be done by one of ordinary skill in the art through routine optimization of a known result-effective variable (MPEP 2144.05.II.B: the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process).
In this case, the amount of hydrogen peroxide removed is a mere change in degree/amount/proportion. It would be advantageous to maximize the amount removed to prevent harm to human beings or chemically interactions with what the containers will hold, as well as to maximize the activation of hydrogen peroxide for greater sterilization effect. Furthermore, the intensity and duration of the UV radiation would be the result effective variable that determines how the amount removed.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Andersson modified by Py to provide enough UV radiation exposure to the hydrogen peroxide to decompose all of it, with the reasonable expectation that the sterilization effect would be maximized while minimizing the amount of harmful residual hydrogen peroxide.
Regarding claim 16, Andersson modified by Py teaches the method of claim 14, as set forth above, and teaches wherein hydrogen peroxide environment is a vapor phase hydrogen peroxide environment (pg. 11 lines 28-29: by partly shown means 23 which is able to vaporise hydrogen peroxide and spray it onto the packaging material).
Regarding claim 18, Andersson modified by Py teaches the method of claim 14, as set forth above, but does not teach wherein said illuminating is performed with pulsed UV light.
Py teaches a similar UV sterilization device involving multiple stations, which also fills containers (abstract: An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum; Fig. 1). Py teaches wherein continuous OR pulsed UV light may be used but that pulsed UV light is quick and effective (par. 58-59: UV sterilization may be accomplished through either continuous wave UV sterilization or pulsed UV sterilization… The use of pulsed UV light allows for quick and effective sterilization of the device 12 as it moves from one workstation to the next).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Andersson modified by Py to used pulsed UV light, as taught by Py, as a quick and effective means of sterilizing a container to be filled.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Andersson modified by Py, as applied to claims 14, 16, and 18 above, in further view of Nunn.
Regarding claim 17, Andersson modified by Py teaches the method of claim 14, as set forth above, and teaches wherein said hydrogen peroxide environment is an interior of a chamber filled with said vapor phase hydrogen peroxide (Fig. 1: station F), but does not teach and wherein separating comprises applying a vacuum to said interior of said chamber.
Andersson already teaches removing surplus hydrogen peroxide (pg. 6 lines 21-25: In an additional presently preferred embodiment said means for applying a first partial quantity of sterilization agent is a bath of sterilization agent through which the packaging material runs, which bath is provided with means adapted to remove surplus sterilization agent when the packaging material emerges from the bath) but does not teach a specific means of doing so.
Nunn teaches wherein a vacuum can help remove and recycle surplus hydrogen peroxide (pg. 4 last par.- pg. 5 par. 1: a vacuum can be pulled below the conveyor, or above the non-woven materials to be treated, respectively, pulling the treatment through the materials to be treated. Excess treatment chemicals can be collected and recycled, if desired).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Andersson modified by Py to use a vacuum to remove excess hydrogen peroxide either after treatment in station B or treatment in station F, as taught by Nunn, in order to fulfill Andersson’s need of a means to remove hydrogen peroxide and also to conveniently recycle the hydrogen peroxide.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding claim 1, Andersson teaches A method for sterilizing at least one workpiece primary container closure system (PCCS) having an interior open to an environment (Fig. 1: station F), comprising:
providing a sterilization cabinet, comprising
a sterilization chamber (Fig. 1: station G),
at least one portal to said sterilization chamber openable to load at least one workpiece PCCS into said sterilization chamber (pg. 11 lines 11-15: When the tubular packaging container blank 7 has been provided with the end wall 9 by injection moulding, it is moved, by (not shown) conveying means, from the injection moulding station shown at E into a closed space or chamber 17 which surrounds a number of processing or treatment stations for the blank 7 located in sequence after the injection moulding station; NOTE: the stations must have an openable portal in order to allow the blanks to enter it),
at least one UV light source that generates UV light directed into said sterilization chamber (Fig. 1: UV lamp 18);
exposing the interior of at least one workpiece item to vapor-phase hydrogen peroxide generated in the environment (Fig. 1: station G, means 23; pg. 11 lines 28-29: by partly shown means 23 which is able to vaporise hydrogen peroxide and spray it onto the packaging material)
sterilizing each workpiece item by applying UV light thereto (Fig. 1: UV lamp 18 in station G, which follows station F where hydrogen peroxide was administered);
causing each workpiece item to exit the sterilization chamber (pg. 12 lines 20-28: As soon as the desired volume of contents has been filled into the packaging container, it is displaced a further step to station J, where the packaging container is treated by (not shown) sealing means for sealing, in liquid-tight fashion, its upwardly facing bottom end. This is realised by means of a seal which is put into effect transversely of the longitudinal direction of the tubular blank and which gives rise to the formation of a sealing fin 22. The fin is then folded down and a planar bottom surface is formed by forming and downward folding of flaps. This folding, which is normally designated final folding, however takes place outside the sterile chamber 17);
wherein said applying decomposes said remnant hydrogen peroxide on the at least one workpiece item (pg. 12 lines 3-8: After the chemical sterilization agent has been applied in station F, the packaging, container blank 7 is displaced to a subsequent station which carries reference designation G. There, the inside of the blank is exposed to irradiation sterilization. The irradiation preferably takes place with UV-light irradiation means in the form of a lamp 18 for UV-light which extends wholly or partly down into the packaging container blank; NOTE: there is no mentioned step of removing the hydrogen peroxide, so it is interpreted to remain on the item as it is illuminated with UV light; furthermore, illuminating the hydrogen peroxide with UV light would have the effect of decomposing it to a finite degree).
but does not teach
wherein the UV light is pulsed.
Py teaches a similar UV sterilization device involving multiple stations, which also fills containers (abstract: An apparatus and method for sterile filling comprises de-contaminating a needle penetrable surface of a device including a needle penetrable septum and a sealed chamber in fluid communication with the needle penetrable septum. A filling needle penetrates the needle penetrable septum, introduces substance through the filling needle and into the chamber and is, in turn, withdrawn from the septum; Fig. 1). Py teaches wherein continuous OR pulsed UV light may be used but that pulsed UV light is quick and effective (par. 58-59: UV sterilization may be accomplished through either continuous wave UV sterilization or pulsed UV sterilization… The use of pulsed UV light allows for quick and effective sterilization of the device 12 as it moves from one workstation to the next).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Andersson to used pulsed UV light, as taught by Py, as a quick and effective means of sterilizing a container to be filled.
Andersson modified by Py still does not teach
substantially UV-transparent
a rotary table movable within said sterilization chamber, wherein said rotary table is substantially UV transparent,
wherein at least one said UV light source is positioned to emit UV light through said rotary table to illuminate the workpiece PCCS and
after said exposing, loading at least one workpiece item onto said rotary table in said sterilization chamber, said rotary table in a loading position
moving said rotary table to move at least one workpiece PCCS to a sterilization position within said sterilization chamber
wherein at least some of said pulsed UV light is emitted by at least one UV light source through said rotary table to a surface of each workpiece PCCS and through the substantially transparent PCCS,
moving said carrier to an unloading position.
While it would be obvious to modify Andersson to sterilize containers that are substantially UV-transparent instead, it would not be obvious to modify Andersson to have a rotary table for administering UV radiation that is separate from a station for spraying hydrogen peroxide.
Hayakawa (WO 2018207787 A1) teaches a rotary table (Fig. 1: 7) with a sterilizer for administering hydrogen peroxide (Fig. 1: 8) but this step occurs in the same environment as the step of administering UV radiation. The claim limitation that the PCCS is sterilized by hydrogen peroxide and then transferred to a rotary table where UV radiation is administered would not be met.
Adriansens (FR 2907684 A1) teaches a hydrogen peroxide administering module (Fig. 1: sterilization station 74) that is located upstream of a UV radiation section featuring a rotating transport path (Fig. 1: UV sterilizing unit 76), but Adriansens specifically teaches that only the inner wall of the containers are to be exposed to hydrogen peroxide, in contrast to the claim limitation requiring that hydrogen peroxide is “on and in” the PCCS (pg. 4: A possible solution is to treat the outer surface of the body of the preform chemically in a manner analogous to the inner wall, that is to say by spraying, upstream of the thermal conditioning oven, a sterilization solution. , such as hydrogen peroxide (H2O2), on the outer surface of the body of the preform. However, tests have shown that the flow of cooling air flowing through the oven causes the almost complete and immediate elimination of most of the sterilization solution applied to the external surface before the sterilizing solution has been removed. It could be activated thermally by the heating means, so that the decontamination of the external surface of the body of the preform thus obtained is generally very weak and therefore insufficient).
Claims 3-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. See analysis above regarding claim 1.
Conclusion
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/C.C./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796