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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/6/2026 is acknowledged.
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.
Claims 3-5, 7-9,11, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3 and 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 requires the liquid waste container being positioned outside the containment enclosure while claim 10, from which claim 11 depends, requires that the liquid waste container is positioned inside the containment enclosure. Claim 11 contradicts claim 10 and it is unclear how the liquid waste container can simultaneously be positioned both inside and outside the containment enclosure.
Claim 4 recites the limitation "said inactivation unit and/or gas decontamination unit". There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "said inactivation unit". There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "said gas decontamination unit". There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the purification unit". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the purification device". There is insufficient antecedent basis for this limitation in the claim.
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.
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 1-3, 5-7, and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cassani et al. (US 5,656,491) and further in view of Guerini et al. (US 2015/0159127) and Sampson (US 2009/0123339).
Regarding claim 1 Cassani discloses a system for the production of cells, viruses or cells- or virus- derived products, comprising a containment enclosure the containment enclosure (1) comprises: (See Cassani Figs and Abstract wherein the device is a system for the production of cells and comprises a containment enclosure, i.e. interior space.)
at least one production unit (2) comprising at least one bioreactor for culturing the cells or virus, said bioreactor is provided with at least one inlet and at least one outlet, and (See Cassani Fig. 3 wherien a production unit comprises at least one bioreactor 18,19, or 20 with various inlets and outlets as shown)
wherein the production unit or any device of said unit is fluidly connected to a liquid waste container inside the containment enclosure and wherein the liquid waste container is adapted for decontaminating the liquid waste inside the containment enclosure, (See Cassani Col. 8 Lines 11-19 wherein wastes from the bioreactor are sent to a liquid waste container and thus they are fluidly connected and said liquid waste is decontaminated by injection of steam and this it is so adapted.)
Cassani discloses all the claim limitations as set forth above as well as providing at least some form of entry and exit for people and materials into and out of the enclosure but does not specifically disclose the specific entry means and exit means designed to open and close.
Guerini et al. discloses a system for the production of cells comprising a containment enclosure with production units and purification units wherein entry means and exit means, i.e. a door or doors, which open and close provide access to the enclosure. (See Guerini Fig. 8-9 and [0034]-[0035] wherein doors, i.e. entry means and exit means, open and close to provide access to the containment unit.) Guerini et al. also discloses at least one process control device, said process control device collects, monitors or records data on actions performed by the units of said system. (See Guerini [0042] wherein a computer, i.e. process control device, collects or monitors, and/or records data on actions performed by units of the system.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide doors which control entry and exit to the containment unit as described by Guerini et al. in the device of Cassani because doors are very well known ways to allow secured access to the interior of spaces which people must access as would be desirable in the device of Cassani.
It also would have been obvious to one of ordinary skill in the art at the time of filing to provide a process control device, i.e. computer, which can collect, monitor, and/or record data on units in a system as described by Guerini et al. in the device of Cassani because such a computer system allows automated control of biomaterial production reducing manual labor and user error as would be desirable in the device of Cassani.
Cassani does not specifically disclose said process control device (9) is programmed to provide status of the decontamination of the liquid waste.
Sampson discloses a waste processing device for decontaminating biohazardous wastes, including liquid waste, utilizing steam wherein a process controller is provided to adjust and provide various forms of status of the decontamination of the waste. (See Sampson Abstract [0015], [0050]-[0058] wherein various status indicators are given by a programmed process control device as the the status of decontamination of biohazardous wastes,i.e. including liquid wastes.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a process control system programmed to provide a status as to waste decontamination as described by Sampson in the device of Cassani because such a device ensures that the waste is properly sterilized and to prevent improper functioning and release of potentially hazardous materials as would be desirable in the device of Cassani.
Regarding claim 2 modified Cassani discloses all the claim limitations as set forth above as well as the device, wherein the process control device (9) comprises at least one data input device through which information on the completion of a predetermined number of actions is entered or recorded in said process control device. (See Guerini et [0042] wherein said process control device comprises a keyboard, i.e. data input device, through which one may enter any information desired into the computer and which us recorded therein.)
Regarding claim 3 modified Cassani discloses all the claim limitations as set forth above but does not specifically disclose the opening and closing of the entry means and exit means being automated by a process control device.
It is noted that such a modification would have required merely automating the opening and closing of the door of modified Cassani which would have been obvious to one of ordinary skill in the art at the time of filing because it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192 (CCPA 1958); In re Rundell, 9 USPQ 220 (CCPA 1931).
Regarding claim 5 modified Cassani discloses all the claim limitations as set forth above as well as the device characterized in that said inactivation unit is connectable to any unit of the containment enclosure. (See Cassani wherein inactivation units, i.e. connecting modules 8 are connectable to any unit of the containment enclosure via openings.)
Regarding claim 6 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein inactivation occurs via inactivation compositions selected from the group comprising formaldehyde, sodium hydroxide, at least one detergent, at least one acid or any combination or solution thereof. (See Cassani Col 7 Lines 19-27 wherein inactivation occurs via the use of at least one detergent.)
Regarding claim 7 modified Cassani discloses all the claim limitations as set forth above as well as the device further comprising a sterilization unit (5), said sterilization unit at least one autoclave for sterilization of solid materials. (See Cassani Col. 7 Lines 35-40 and Col. 8 Lines 11-12 wherein an autoclave, i.e. sterilization unit, is provided to sterilize solid materials.)
Regarding claim 9 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the bioreactor or the purification unit is fluidly connected to a liquid waste container. (See Cassani Col. 8 Lines 11-19 wherein wastes from the bioreactor are sent to a liquid waste container and thus they are fluidly connected.)
Regarding claim 10 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the liquid waste container is positioned inside the containment enclosure. (See Cassani Col. 8 Lines 11-19 wherein a single container is a liquid waste container positioned inside the enclosure)
Regarding claim 11 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the liquid waste container is positioned outside the containment enclosure. (See Cassani Col. 8 Lines 11-19 wherein there is a treatment tank, i.e. liquid waste container, located outside the enclosure.)
Regarding claim 12 modified Cassani discloses all the claim limitations as set forth above as well as the device further comprising at least one waste decontamination device contained in the containment enclosure (1) for decontamination of any liquid waste, said waste decontamination device is positioned upstream or downstream the liquid waste container. (See Cassani Col. 8 Lines 11-19 wherein a waste decontamination device, i.e. steam injector, is provided upstream and/or downstream of a liquid waste container.)
Regarding claim 13 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein at least one temperature is maintained in the different units of the containment enclosure. (See Cassani Col. 3 Line 58- Col. 4 Line 2 wherein there is an air conditioning system which maintains the different units of the containment enclosure at preset temperatures.)
Regarding claim 14 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the purification device is provided with an inlet which is fluidly connected to the outlet of the bioreactor and is selected from the group comprising an ultrafiltration device, a diafiltration device, a centrifugation device, a washing device, a chromatography column or any combination thereof. (See Cassani Figs. 3-4 wherein the outlet 34 from a bioreactor is fluidically connected to centrifuge 50.)
Regarding claim 15 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the process control device controls the cell or virus culture or purification or inactivation or disinfection processes, and is connectable to at least one unit of the containment enclosure. (See Guerini [0058] wherein the process control device controls cell culture operations and is connectable to the production unit to perform such control.)
Regarding claim 16 modified Cassani discloses all the claim limitations as set forth above as well as the device wherein the entry (7) and exit means (8) are the same, and allow entering and exiting the containment enclosure (1). (See Guerini Fig. 3 wherein the door 218 may be the entry and exit means, i.e. the entry and exit means are the same door.)
Regarding claim 17 modified Cassani discloses all the claim limitations as set forth above as well as the device characterized in that said containment enclosure (1) is enclosed by a containment unit. (See Cassani Fig.2 wherein the containment enclosure is enclosed by a containment unit 1, i.e. exterior thermally insulated walls.)
Claims 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cassani et al. (US 5,656,491) in view of Guerini et al. (US 2015/0159127) and Sampson (US 2009/0123339) as applied to claims above, and further in view of Merino et al. (US 2016/0128886).
Regarding claims 3 and 4 it is noted that modified Cassani does not specifically disclose the opening and closing of the entry means and exit means being automated by a process control device.
Merino discloses a containment unit wherein the opening and closing of doors is controlled by a process control device and said process control device is programmed to provide access to said containment enclosure, once said process control device has received information related to said an inactivation unit or a gas decontamination unit. (See Merino Abstract [0027]-[0028], [0033], and [0049]-[0052] wherein a process control device, i.e. programmed computer, controls the opening and closing of doors based upon information received from an HVAC system, i.e. gas decontamination unit to ensure areas remain sterile.)
It would have been obvious to one of ordinary skill in the art a the time of filling to provide a process control device which controls access by opening and closing doors only when certain parameters are met, i.e. information is received from a gas decontamination unit, as described by Merino in the device of modified Cassani because such control prevents unwanted contaminants from entering the device as would be desirable in the device of modified Cassani.
Regarding claim 8 modified Cassani discloses a gas contamination unit connected to units of the enclosure which provides steam and other chemical gas decontamination means but does not specifically disclose the use of hydrogen peroxide, aerosol, formaldehyde vaporizing devices, hydrogen peroxide vaporizing devices, aerosol vaporizing devices or any combination thereof.
Merino discloses a containment unit comprising a gas contamination unit connected to the containment unit which provides decontamination of materials entering or exiting the device by utilizing hydrogen peroxide. (See Merino [0032])
It would have been obvious to one of ordinary skill in the art a the time of filling to provide a gas decontamination means comprising hydrogen peroxide because hydrogen peroxide is known in the art to decontaminate areas which need to remain sterile and effectively prevents materials and people entering the device form contaminating an area as would be desirable in the device of modified Cassani.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,036,549 in view of Sampson (US 2009/012339).
The claims of U.S. Patent No. 12,036,549 are generally more specific than claims 1-17 and teach all limitations of claims 1-17 with the exception of said process control device being programmed to provide status of the decontamination of the liquid waste.
Sampson discloses a waste processing device for decontaminating biohazardous wastes, including liquid waste, utilizing steam wherein a process controller is provided to adjust and provide various forms of status of the decontamination of the waste. (See Sampson Abstract [0015], [0050]-[0058] wherein various status indicators are given by a programmed process control device as the the status of decontamination of biohazardous wastes,i.e. including liquid wastes.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a process control system programmed to provide a status as to waste decontamination as described by Sampson in the device of U.S. Patent No. 12,036,549 because such a device ensures that the waste is properly sterilized and to prevent improper functioning and release of potentially hazardous materials as would be desirable in the device of U.S. Patent No. 12,036,549 .
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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