DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-2, 4-12, 14-15, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kleinmann (US 20190151488 A1).
Regarding claim 1, Kleinmann teaches an isolator for processing medical substances (isolator for pharmaceutical applications, abstract), comprising: a working space sealed off from the environment (Figure 1 manipulation chamber “3”), at least one supply line and/or one discharge line for supply and/or discharging a gas to and/or from at least one machine component arranged inside the working space (manipulator supply line connected to ultrafine distributing means to supply manipulator chamber with decontaminant/air, abstract), wherein the supply line and/or discharge line is in fluid communication with the working space (supply line supplies manipulator chamber with decontaminant/air, abstract), a decontamination device for decontaminating the isolator by introducing a decontaminant (Figure 1 decontaminate “20” supplied from a stock “21”), wherein the decontamination device comprises at least a first decontamination line for introducing the decontaminant (Figure 1 shared supply line “29” connects decontaminant stock “21” to chambers “4” and “3”), wherein the decontamination device is configured to supply at least part of the decontaminant to the working space of the isolator via the first decontamination line and at least partially via the supply line and/or discharge line (Figure 1 shared supply line “29” branches into plenum supply line “26” and multiple manipulator supply lines “27”), wherein the machine component is configured as a pneumatically actuated gripper, robot arm, hose, tube, valve, or needle (Figure 1 cylindrical distribution tubes “16” disposed in manipulation chamber “3”).
Regarding claim 2, Kleinmann teaches wherein the supply line is a working gas supply line for a working gas during an operation of the isolator (Figure 1 carrier gas line “23” to supply carrier gas).
Regarding claim 4, Kleinmann teaches wherein the decontamination device for introducing the decontaminant comprises at least a second decontamination line and is configured to supply at least a part of the decontaminant via the second decontamination line into the working space of the isolator (Figure 1 shared supply line “29” branches into plenum supply line “26” and multiple manipulator supply lines “27”).
Regarding claim 5, Kleinmann teaches wherein the isolator comprises a flushing device for removing the decontaminant, which is configured to supply a flushing medium via the first decontamination line and at least partially via the supply and/discharge line and/or second decontamination line into the working space of the isolator (Figure 1 fresh air supplied via supply line “17” and carrier air flows through carrier line “23” in addition to circulation from fan “7” and removal via the exhaust line “15” during purge phase, paragraph [0047], and decontaminant vapor is swept along by carrier air, paragraph [0040]).
Regarding claim 6, Kleinmann teaches wherein the decontamination device comprises an evaporator configured to convert the decontaminant by evaporation from a liquid phase and/or solid phase to a gaseous phase (flash evaporator for evaporating decontaminant from a stock, paragraph [0040]).
Regarding claim 7, Kleinmann teaches the decontamination device comprises a compressed air supply which is in fluidic communication with the evaporator, the first decontamination line, and/or a second decontamination line (use of sterile pressurized air as a carrier air for hydrogen peroxide, paragraph [0031], and Figure 1 carrier line “23” connected to evaporator “19”).
Regarding claim 8, Kleinmann teaches a method for decontamination of an isolator (isolator for pharmaceutical applications, abstract) with a working space sealed off from its environment (Figure 1 manipulation chamber “3”), at least one supply and/or discharge line for supplying and/or discharging a gas to and/or from at least one machine component (manipulator supply line connected to ultrafine distributing means to supply manipulator chamber with decontaminant/air, abstract), wherein the machine component is configured as a pneumatically actuated gripper, robot arm, hose, tube, valve, or needle (Figure 1 cylindrical distribution tubes “16” disposed in manipulation chamber “3”), wherein the supply and/or discharge line is in fluidic communication with the working space (supply line supplies manipulator chamber with decontaminant/air, abstract), wherein the method comprises the following steps: introducing a decontaminant into the working space of the isolator (Figure 1 decontaminate “20” supplied from a stock “21”) via at least one first decontamination line and at least partially via the supply and/or discharge line (Figure 1 shared supply line “29” branches into plenum supply line “26” and multiple manipulator supply lines “27”).
Regarding claim 9, Kleinmann teaches wherein the method further comprises introducing the decontaminant into the working space via a second decontamination line (Figure 1 shared supply line “29” branches into plenum supply line “26” and multiple manipulator supply lines “27”).
Regarding claim 10, Kleinmann teaches wherein the method further comprises the step of converting the decontaminant from a liquid and/or solid phase to a gaseous phase (flash evaporator for evaporating decontaminant from a stock, paragraph [0040]).
Regarding claim 11, Kleinmann teaches wherein the method further comprises the step of pressurizing the decontaminant with compressed air (use of sterile pressurized air as carrier air for hydrogen peroxide, paragraph [0031]).
Regarding claim 12, Kleinmann teaches introducing a flushing medium via the first decontamination line and at least partially via the supply and/or discharge line and/or via the second decontamination line into the working space (Figure 1 fresh air supplied via supply line “17” and carrier air flows through carrier line “23” in addition to circulation from fan “7” and removal via the exhaust line “15” during purge phase, paragraph [0047], and decontaminant vapor is swept along by carrier air, paragraph [0040]).
Regarding claim 14, Kleinmann teaches wherein the decontaminant is a gaseous decontaminate (evaporated hydrogen peroxide, paragraph [0040]).
Regarding claim 15, Kleinmann teaches wherein the decontaminant is hydrogen peroxide (evaporated hydrogen peroxide, paragraph [0040]).
Regarding claim 17, Kleinmann teaches wherein the flushing medium is compressed air (decontaminant vapor is swept along by carrier air, paragraph [0040], and use of sterile pressurized air as a carrier air for hydrogen peroxide, paragraph [0031]).
Regarding claim 18, Kleinmann teaches wherein the decontaminant is a gaseous decontaminate (evaporated hydrogen peroxide, paragraph [0040]).
Regarding claim 19, Kleinmann teaches wherein the decontaminant is hydrogen peroxide (evaporated hydrogen peroxide, paragraph [0040]).
Regarding claim 20, Kleinmann teaches wherein converting the decontaminant from a liquid and/or solid phase to a gaseous phase includes using an evaporator (flash evaporator for evaporating decontaminant from a stock, paragraph [0040]).
Regarding claim 21, Kleinmann teaches wherein the flushing medium is compressed air (decontaminant vapor is swept along by carrier air, paragraph [0040], and use of sterile pressurized air as a carrier air for hydrogen peroxide, paragraph [0031]).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kleinmann in view of An (CN 212146519 U).
Regarding claim 3, Kleinmann teaches all aspects of the current invention as discussed above except wherein the discharge line is a particle measuring line via which a sample of the air in the working space can be drawn off via the particle measuring line and can be fed to a particle measuring device. However, An teaches wherein the discharge line is a particle measuring line via which a sample of the air in the working space can be drawn off via the particle measuring line and can be fed to a particle measuring device (bacteria sampling system includes airborne bacteria sampler installed in operation chamber connected to sampling pipe and pump pipe, paragraph [0033]).
Kleinmann and An are considered analogous to the current invention because all are in the field of decontaminating isolator devices. Therefore, it would have been obvious to one of ordinary skill in the art to combine the isolator taught by Kleinmann with the bacteria sampling system taught by An because An teaches the integration of the sampling system into the isolator guarantees the accuracy of the sampling results and the sterile environment inside of the isolator (paragraph [0045]).
Regarding claim 16, the combination of Kleinmann and An teaches wherein the particle measuring device is part of the isolator (bacteria sampling system installed in the isolator, paragraph [0033], An).
Conclusion
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799