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 Objections
Claims 2-23 are objected to because of the following informalities: “A prefabricated unmanned and gloveless cleanroom processing enclosure” should read “The prefabricated unmanned and gloveless cleanroom processing enclosure”.
Claim 4 is objected to because of the following informalities: “arranged to permit locomotion of the or each remotely haptically controllable robot” should read “arranged to permit locomotion of one or each remotely haptically controllable robot”.
Claim 15 is objected to because of the following informalities: “in which the decontamination system comprises” should read “comprising a decontamination system further comprising”, or be amended to depend upon claim 14 instead of claim 13 for proper antecedent basis of “the decontamination system”.
Claim 19 is objected to because of the following informalities: “in which one or more of the service and/or utility ports comprises” should read “comprising one or more of the service and/or utility ports further comprising”, or be amended to depend upon claim 18 instead of claim 17 for proper antecedent basis of “one or more of the service and/or utility ports”.
Claim 23 is objected to because of the following informalities: “according claim 1” should read “according to claim 1”. Appropriate correction is required.
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.
Such claim limitation(s) is/are:
Claim 15: “the decontamination system comprises a source of decontaminant, means for injecting the decontaminant into the at least one interior zone and means for extracting the decontaminant”
With regards to the means for injecting the decontaminant of claim 15, the corresponding structure described on page 9 lines 25-26 of the 04/09/2024 specification is an “array of nozzles”.
With regards to the means for extracting the decontaminant of claim 15, the corresponding structure described on page 9 lines 28-29 of the 04/09/2024 specification is an “HVAC system 42”.
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.
Claim(s) 1-7, 9, 11-12, 14, 16-17, 20-21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026.
Regarding claim 1, Bechini teaches
a prefabricated unmanned and gloveless cleanroom processing enclosure (containment means 9, fig. 1A-1B) comprising at least one interior zone (inner chamber 91, fig. 1A);
at least one automated product processing module located in the at least one interior zone (two process units 3, fig. 1C; located on exchange module 95, fig. 5); and
at least one robot operable within the at least one zone to effect interventional actions (two robots 1, 2)
Bechini does not teach
at least one remotely haptically controllable robot operable within the at least one zone to effect interventional actions
Watanabe teaches
at least one remotely haptically controllable robot (manipulator 3; haptically controlled as described in [0031-0034]) operable within the at least one zone to effect interventional actions (operable within working room 1)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the haptically controlled robot system of Watanabe to the system of Bechini, since “in cell culture, even if the same operation is performed under the same conditions, the results of each operation are not always the same. For this reason, the operator who performs the actual operation needs to adjust the content of the operation to be performed next according to the result of each operation while conforming to the protocol. Also, with regard to the content of each operation, it is also difficult to describe the specific content of the protocol in the protocol, such as an operation that does not give excessive physical shock to the cell, handling that does not destroy the cultured cell mass There are many. For this reason, cell culture in regenerative medicine or the like has a large part depending on the experience and skill of the worker, and the difference in skill between experts and non-skilled persons gives the success or failure of cell culture and efficiency A large impact. In addition, the need for various adjustments according to the progress of cell culture is also a factor that makes automation of cell culture difficult” [0004-0005 of Watanabe]; thus allowing for an operator to control the system when process changes needed to be made to an operation.
Regarding claim 2, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1
comprising a plurality of product processing modules (fig. 8 comprising a plurality of containment means 9, thus a plurality of process units 3)
Regarding claim 3, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 2 comprising
a plurality of remotely haptically controllable robots within the at least one zone (Bechini comprises two robots 1, 2 as shown on fig. 1B; Watanabe also comprises two hands 32 as shown on fig. 1)
Regarding claim 4, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the at least one interior zone is arranged to permit locomotion of the or each remotely haptically controllable robot within the at least one interior zone (as describe in [0032] of Watanabe)
Regarding claim 5, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the enclosure defines a plurality of interior zones (plurality of inner chambers 91 associated with plurality of containment means 9, fig. 8)
Note: Applicant is advised that should claim 5 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Regarding claim 6, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the enclosure defines a plurality of interior zones (plurality of inner chambers 91 associated with plurality of containment means 9, fig. 8)
Regarding claim 7, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 comprising
one or more access ports in an envelope of the enclosure (first through-opening 917)
Regarding claim 9, Bechini, as modified, teaches the a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 7 in which
one or more of the access ports are adapted for coupling with a supply container (“Receptacles 70 made available in a sorting grid 800 in a tray 8 are brought to the through-opening 917 at the input side” [0066 of Bechini]; thus, since through-opening 917 is adapted to bring receptacles 70 into the containment means 9, through-opening 917 is adapted for coupling with a supply container (fig. 8, wherein an upstream containment means 9 reads on a “supply container” for a downstream containment means 9)
Regarding claim 11, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 comprising
a HVAC system operable to establish and/or regulate environmental conditions within the enclosure (“During the operation of the containment means 9 , a typical laminar airflow L is introduced from above through the inflow air filter 94 into the chamber 91”) [0064]
Regarding claim 12, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 11 in which
the HVAC system comprises at least one upper air supply (via inflow air filter 94, fig. 1A) and at least one lower air return (via outflow air filter 940, fig. 1A)
Regarding claim 14, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 comprising
a decontamination system operable to decontaminate the interior of the enclosure (“The containment means is configured as… an isolator with an air treatment device of clean-room classification and a decontamination device” [0030])
Regarding claim 16, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to any preceding claim 1 in which
the enclosure is adapted to establish and maintain positive or negative pressurization
Watanabe teaches
the enclosure is adapted to establish and maintain positive or negative pressurization (“a filter unit 12 for filtering a gas (for example, air outside the working chamber 1) sent from a fan (not shown) is provided on the ceiling portion of the housing 10 constituting the work chamber 1 Has been done. Further, in the work chamber 1, an exhaust unit (not shown) for adjusting the pressure inside the housing 10 is provided”) [0023]
Bechini teaches an inflow air filter 94 and outflow air filter 940 for the intake and exhaust or air, however does not teach a system to establish and maintain positive or negative pressurization. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the exhaust unit of Watanabe to the containment means 9 of Bechini, thus allowing the system to maintain a negative pressure in order to trap particles within the containment means in the event of a breach.
Regarding claim 17, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to any preceding claim 1 in which
the enclosure is adapted to establish, monitor and/or maintain cleanroom operating conditions within the one or more interior zones
Watanabe teaches
the enclosure is adapted to establish, monitor and/or maintain cleanroom operating conditions within the one or more interior zones (“a filter unit 12 for filtering a gas (for example, air outside the working chamber 1) sent from a fan (not shown) is provided on the ceiling portion of the housing 10 constituting the work chamber 1 Has been done. Further, in the work chamber 1, an exhaust unit (not shown) for adjusting the pressure inside the housing 10 is provided” [0023]; “monitor” conditions is not required due to use of “or” language)
Bechini teaches an inflow air filter 94 and outflow air filter 940 for the intake and exhaust or air, however does not teach a system to establish and maintain positive or negative pressurization. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the exhaust unit of Watanabe to the containment means 9 of Bechini, thus allowing the system to maintain a negative pressure in order to trap particles within the containment means in the event of a breach.
Regarding claim 20, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the enclosure is adapted for the modular connection to one or more duplicate and/or complimentary enclosures (fig. 8 comprising a plurality of duplicate containment means 9)
Regarding claim 21, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the enclosure is adapted to be unitarily transportable via one or more modes of transport
However, In re Lindberg, 194 F.2d 732, 93 USPQ 23, the federal circuit held that a claimed device is portable or movable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results. Therefore, the claimed portable configuration of the enclosure does not distinguish the claimed invention over the prior art since it does not produce a new or unexpected result for the system.
Regarding claim 23, Bechini, as modified, teaches a prefabricated automated unmanned and gloveless cleanroom processing enclosure according claim 1 in which
the enclosure is prequalified (it is inherent to a machine to be functional prior to use, thus containment means 9 reads on the claimed “prequalified” enclosure)
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, in further view of Gohier (US20200338765A1).
Regarding claim 8, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 7 in which
one or more of the access ports comprises a rapid transfer port
Gohier teaches
one or more of the access ports comprises a rapid transfer port (“tight ports 38 , in particular of the RTP (Rapid Transfer Port) type”) [0049]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the first through-opening 917 of Bechini as a rapid transfer port, as taught in Gohier, in order to allow the system to transfer articles into the isolator without breaking containment within the isolator.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, in further view of Guelmami (US20170312745A1).
Regarding claim 10, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1
comprising one or more airlocks
Guelmami teaches
comprising one or more airlocks (airlock system 12)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the first through-opening 917 of Bechini as an airlock, as taught in Guelmami, in order to allow the system to transfer articles into the isolator without breaking containment within the isolator.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, in further view of Lichnewsky (US20200407207A1).
Regarding claim 13, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 11 in which
the HVAC system comprises one or more HEPA and/or ULPA filters
Lichnewsky teaches
the HVAC system comprises one or more HEPA and/or ULPA filters (“each filtering unit may comprise one or more filters of a known type (for example, HEPA or ULPA filters) and one or more fans operatively coupled to the corresponding filters”) [0015]
While Bechini teaches inflow air filter 94 and outflow air filter 940, Bechini does not explicitly describe the types of filters used. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the inflow air filter 94 and outflow air filter 940 as HEPA or ULPA filters, as taught in Lichnewsky, in order to provide a filter that is known in the art to effectively trap a large percentage of contaminants.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, and Lichnewsky (US20200407207A1), in further view of Nishimura (US20190193287A1).
Regarding claim 15, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 13 in which
the decontamination system comprises a source of decontaminant, means for injecting the decontaminant into the at least one interior zone and means for extracting the decontaminant
Nishimura teaches
the decontamination system (decontamination means 13) comprises a source of decontaminant (“decontamination gas such as hydrogen peroxide steam as a decontamination medium”) [0029], means for injecting the decontaminant (supply pipe 13A) into the at least one interior zone (work space W) and means for extracting the decontaminant (discharge pipe 13B)
Bechini discloses a decontamination device in [0030], however does not further describe the structure of the system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the decontamination system of Nishimura to Bechini, as modified, in order to effectively provide sufficient structure to decontaminate the system prior to use.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, in further view of Dabrowski (WO2020009700A1).
Regarding claim 18, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 comprising
one or more service and/or utility ports
Dabrowski teaches
one or more service and/or utility ports (standard format utility interface 360, fig. 3C-3D)
Bechini teaches a modular containment means 9 comprising electrical components (such as robots 1, 2), however does not explicitly teach a utility port for supplying electrical utilities. Dabrowski teaches a similar modular equipment array 300, however further provides standard format utility interface 360. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the standard format utility interface 360 of Dabrowski to Bechini, as modified, in order to effectively supply operational capability to the electrical components of containment means 9 of Bechini.
Regarding claim 19, Bechini, as modified, teaches prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 17 in which
one or more of the service and/or utility ports comprises a water port, electrical connector, data connector, or gas port
Dabrowski teaches
one or more of the service and/or utility ports comprises a water port, electrical connector, data connector, or gas port (standard format utility interface 360, fig. 3C-3D; “Each of the modules is provided with a standard format utility interface 360 (see FIG. 3D for detail). Utilities are provided from a series of supply lines 362 which connect to sources of gasses, liquids, power, and vacuum” [0047])
Bechini teaches a modular containment means 9 comprising electrical components (such as robots 1, 2), however does not explicitly teach a utility port for supplying electrical utilities. Dabrowski teaches a similar modular equipment array 300, however further provides standard format utility interface 360. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the standard format utility interface 360 of Dabrowski to Bechini, as modified, in order to effectively supply operational capability to the electrical components of containment means 9 of Bechini.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bechini (US20190315004A1) in view of Watanabe (JP6472868B2), referring to the English translation dated 06/25/2026, in further view of Hosek (US20200262060A1).
Regarding claim 22, Bechini, as modified, does not teach a prefabricated automated unmanned and gloveless cleanroom processing enclosure according to claim 1 in which
the enclosure has maximum external dimensions equivalent to an intermodal transport container
Hosek teaches
the enclosure has maximum external dimensions equivalent to an intermodal transport container (“A modular system may allow for scalability and eliminate the need to manufacture and transport oversized components”) [0083]
While Bechini teaches a modular enclosure system, it does not explicitly teach the containment means 9 as dimensioned to fit within intermodal transport container. Hosek teaches a similar modular system, wherein the modular components are sized to prevent the need to “transport oversized components” [0083], thus inherently sized to fit on a transport freight container. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the modular components of Bechini as taught in Hosek, in order to allow the system to be easily transported to reduce costs and improve shipping logistics.
Conclusion
The prior art of record not relied upon includes:
Izumi (US20140277714A1), which teach similar modular unmanned and gloveless cleanroom processing enclosure to that claimed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRETT P. MALLON whose telephone number is (571)272-4749. The examiner can normally be reached Monday-Thursday from 8am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HOANG can be reached at (571)272-6460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRETT P. MALLON/Examiner, Art Unit 3762 /MICHAEL G HOANG/Supervisory Patent Examiner, Art Unit 3762
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