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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 July 2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Claim amendments filed 27 July 2026 are acknowledged. Claims 1, 3-12, and 14-21 are pending with claims 2 and 13 being cancelled.
Response to Arguments
Applicant's arguments filed 27 July 2026 have been fully considered but they are not persuasive.
The newly added limitations “a recirculated air supply and a recirculated air discharge for circulating air within the working space” and “wherein the recirculated air supply and the recirculated air discharge are separate lines from the working gas supply line” to claims 1 and 8 are not sufficient to overcome the 35 U.S.C. 103 rejection with respect to Kleinmann in view of Mauck. While it is true that Mauck does not teach separate air circulation and inert working gas circulation loops, Kleinmann teaches an air circulation loop (Figure 1 fresh air line “17” to supply conditioned air and exhaust air line “15” to discharge air) separate from decontaminate gas supply (Figure 1 shared supply line “29”). Therefore, a combination of Kleinmann and Mauck would render the current invention obvious.
Following the above logic, the 35 U.S.C. 103 rejections of claims 1, 4-12, 14-15, and 17-21 with respect to Kleinmann in view of Mauck are maintained. Similarly, the 35 U.S.C. 103 rejections of claims 3 and 16 with respect to Kleinmann and Mauck in view of An are maintained.
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 1, 4-12, 14-15, and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kleinmann (US 20190151488 A1) in view of Mauck (US 20130252533 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 recirculated air supply and a recirculated air discharge for circulating air within the working space (Figure 1 fresh air line “17” to supply conditioned air and exhaust air line “15” to discharge air), and 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 recirculated air supply and the recirculated air discharge are separate lines from the working gas supply line (Figure 1 shared supply line “29” separate from fresh air line “17” and exhaust air line “15”) but does not teach wherein the supply line at least includes a working gas supply line for supplying a working gas during operation of the isolator, and wherein the working gas is used for pneumatic control of the machine component, wherein the mechanic component is configured as pneumatically actuated gripper or robot arm. However, Mauck teaches wherein the supply line at least includes a working gas supply line for supplying a working gas during operation of the isolator, and wherein the working gas is used for pneumatic control of the machine component, wherein the mechanic component is configured as pneumatically actuated gripper or robot arm (various pressurized inert gas loops that can include a pneumatic robot, paragraph [0056], and where the transport of the substrate is completed by the transport robot, paragraph [0058]).
Kleinmann and Mauck 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 pneumatic control of a robot arm taught by Mauck because Mauck teaches that pneumatic apparatuses provide low-particle generating performance as well as being low maintenance (paragraph [0128]).
Regarding claim 4, the combination of Kleinmann and Mauck 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”, Kleinmann).
Regarding claim 5, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 6, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 7, the combination of Kleinmann and Mauck 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”, Kleinmann).
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”), a recirculated air supply and a recirculated air discharge for circulating air within the working space (Figure 1 fresh air line “17” to supply conditioned air and exhaust air line “15” to discharge air), and 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 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”), wherein the recirculated air supply and the recirculated air discharge are separate lines from the working gas supply line (Figure 1 shared supply line “29” separate from fresh air line “17” and exhaust air line “15”), but does not teach wherein the supply line includes at least a working gas supply line for supplying a working gas during an operation of the isolator wherein the working gas is used for pneumatic control of the machine component and wherein the machine component is configurated as a pneumatically actuated gripper or robot arm. However, Mauck teaches wherein the supply line includes at least a working gas supply line for supplying a working gas during an operation of the isolator wherein the working gas is used for pneumatic control of the machine component and wherein the machine component is configurated as a pneumatically actuated gripper or robot arm (various pressurized inert gas loops that can include a pneumatic robot, paragraph [0056], and where the transport of the substrate is completed by the transport robot, paragraph [0058]).
Kleinmann and Mauck are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the isolator taught by Kleinmann with the pneumatic control of a robot arm taught by Mauck because Mauck teaches that pneumatic apparatuses provide low-particle generating performance as well as being low maintenance (paragraph [0128]).
Regarding claim 9, the combination of Kleinmann and Mauck 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”, Kleinmann).
Regarding claim 10, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 11, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 12, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 14, the combination of Kleinmann and Mauck teaches wherein the decontaminant is a gaseous decontaminate (evaporated hydrogen peroxide, paragraph [0040], Kleinmann).
Regarding claim 15, the combination of Kleinmann and Mauck teaches wherein the decontaminant is hydrogen peroxide (evaporated hydrogen peroxide, paragraph [0040], Kleinmann).
Regarding claim 17, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 18, the combination of Kleinmann and Mauck teaches wherein the decontaminant is a gaseous decontaminate (evaporated hydrogen peroxide, paragraph [0040], Kleinmann).
Regarding claim 19, the combination of Kleinmann and Mauck teaches wherein the decontaminant is hydrogen peroxide (evaporated hydrogen peroxide, paragraph [0040], Kleinmann).
Regarding claim 20, the combination of Kleinmann and Mauck 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], Kleinmann).
Regarding claim 21, the combination of Kleinmann and Mauck 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], Kleinmann).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kleinmann and Mauck in view of An (CN 212146519 U).
Regarding claim 3, the combination of Kleinmann and Mauck 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, Mauck 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 and Mauck 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, Mauck, and An teaches wherein the particle measuring device is part of the isolator (bacteria sampling system installed in the isolator, paragraph [0033], An).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
Prosecution Insights