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 of Group I in the reply filed on 5/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins (US 2019/0358633).
Regarding claim 1 Collins discloses a cell culture system comprising: a first pump; and a first cell culture container and a second cell culture container, wherein the first cell culture container has a first culture medium circulation flow path, the second cell culture container has a second culture medium circulation flow path independent of the first culture medium circulation flow path, the first culture medium circulation flow path and the second culture medium circulation flow path are fluidly connected to the first pump, (See Collins Abstract and Figs. 22A-37B wherein a first and second cell culture containers, i.e. wells, are each provided with separate respective first and second culture medium circulation flow paths connected to a first pump.)
and the first culture medium circulation flow path and the second culture medium circulation flow path are fluidly connected to a first culture medium collection container and a second culture medium collection container respectively. (See Collins Abstract [0168] and Figs. 22A-37B wherein the first and second medium circulation flow paths are connected to collection containers, i.e. waste and waste wells.)
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Collins (US 2019/0358633) as applied to claims above.
Regarding claim 3 it is noted that providing additional second pump and third and fourth cell culture containers would require a mere duplication of parts, i.e. duplication of the system of claim 1, which would have been obvious to one of ordinary skill in the art at the time of filing to increase device throughput and reduce the time required to perform analysis and because mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (US 2019/0358633) as applied to claims above, and further in view of Chiu et al. (US 2021/0178398).
Regarding claims 2 and 5 Collins discloses all the claim limitations as set forth above as well as the device wherein the first culture medium circulation flow path is fluidly connected to a culture medium supply container (See Collins Figs. 23A-37B) but does not disclose the use of a rack to hold the containers and being detachably to first base.)
Chiu et al. discloses a module for use in sample processing devices wherein a base is provided with a removable rack for holding containers in sample processing systems in order to securing and accurately place sample and fluid containers. (See Chiu Abstract [0004] and Figs wherein a base 101 holds a rack 200,300, 400, which holds fluid vessels therein.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a base and rack for holding all the fluid vessels of Collins as described by Chiu because the use of such a base and rack allow for secure and accurate holding of vessels for additions and removal of material as would be desirable in the device of Collins.
Claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (US 2019/0358633) in view of Chiu et al. (US 2021/0178398) as applied to claims above, and further in view of Allbritton et al (US 2020/0087515).
Regarding claims 6-7 Collins discloses all the claim limitations as set forth above as well as the use of trans well membrane plates but does not describe the specifics thereof.
Allbritton discloses disposable transwell culture plates wherein a first cell culture container includes an oxygen-permeable membrane disposed in the first cell culture container, the membrane partitioning a first storage portion in which a first culture medium is stored and a second storage portion in which a second culture medium having a dissolved oxygen concentration lower than a dissolved oxygen concentration of the first culture medium is stored. (See Allbritton Abstract, Figs1C and 1H and [0171] and [0183] wherein an oxygen permeable membrane 170 separates the first container into first and second portions storing media having various DO concentrations.)
The first cell culture container has a container main body,a cell culture insert including a tubular portion, the cell culture insert having a bottom surface on which the membrane is disposed, (See Allbritton Fig. 1H wherein the container has a main body 120 a insert 340 with a bottom membrane surface 170.) and a cover member that seals the container main body, (See Allbritton Fig. 1H Cover 360)
the container main body includes an upper wall provided with an opening, a bottom wall facing the upper wall with a space being interposed between the bottom wall and the upper wall, and a side wall contiguous to the upper wall and the bottom wall,(See Allbritton Fig. 1H wherein amin body has bottom 122 open top at upper wall 126 and sidewall 124 contiguous therebetween.)
a first end of the tubular portion is closed by the membrane, a second end of the tubular portion is closed by the cover member, the tubular portion is inserted in the opening of the upper wall such that the first end of the tubular portion is located in inside of the container main body, the first culture medium is stored in the inside of the container main body, and the second culture medium is stored in inside of the tubular portion. (See Allbritton Fig. 1H-1J closed by membrane 170 at a bottom end and a top end by cover 360 and the tubular portion is located in the container main body with culture mediums inside the main body and the tubular portion.)
It would have been obvious to one of ordinary skill in the art at the time of invention to utilize a cell culture transwell as described by Allbritton as the exact cell culture transwell required by Collins because such a device allows the generation of gaseous gradients so that cells may be cultured under more accurate conditions and may be studied as would be desirable in the device of Collins and one would have a reasonable expectation of success in so doing.
Regarding claim 8 modified Collins discloses all the claim limitations as set forth above as well as the device wherein first tube and a second tube; and a culture medium supply container and a culture medium collection container, wherein a first end of the first tube and a first end of the second tube are inserted in the cover member of the first cell culture container and are connected to the inside of the tubular portion, a second end of the first tube and a second end of the second tube are respectively connected to the culture medium supply container and the culture medium collection container, and the first pump is configured to deliver the second culture medium from the culture medium supply container to the inside of the tubular portion of the first cell culture container via the first tube, and to deliver the second culture medium from the inside of the tubular portion of the first cell culture container to the culture medium collection container via the second tube. (See Collins Figs. 23A-37B and Allbritton Figs. 1H-1J wherein tubes are connected to the tubular portion of the insert via the lid and to/from a culture medium supply container and collection container and the pump delivers media from the supply container to inside the tubular portion and from therein to the collection container via the first and second tubes.)
Regarding claim 9 modified Collins discloses all the claim limitations as set forth above as well as the device wherein the cell culture insert is detachable from the container main body,the cover member is detachable from the cell culture insert, the first tube and the second tube are respectively detachable from the culture medium supply container and the culture medium collection container, the first tube and the second tube are each detachable from the first pump, and the first tube and the second tube are detachable from the cover member of the first cell culture container. (See Allbritton Fig. 1H wherein the culture insert, lid, and main body are all detachable from each other and tubes inserted therein and Collins Fig. 1 and Figs. 37A-37B wherein tubes, pumps, and containers are all detachable from one another.)
Regarding claim 11 modified Collins discloses all the claim limitations as set forth above as well as the device, wherein the first base is provided with a recess in which the first cell culture container and the second cell culture container are disposed, and a spring is embedded in the first base to generate biasing force toward the side wall of each of the first cell culture container and the second cell culture container disposed in the recess. (See Chiu Figs. 1-21 wherein the base includes a recess therein and a spring 820 is disposed therein the generate a biasing force toward the sidewall of each container disposed in the recess.)
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Collins (US 2019/0358633) in view of Chiu et al. (US 2021/0178398) and Allbritton et al (US 2020/0087515) as applied to claims above, and further in view of Nakajima et al. (US 2014/0045252)
Regarding claim 12 Collins discloses all the claim limitations as set forth above but does not specifically disclose an electrode arrangement.
Nakajima et al. discloses a transwell device comprising a first lead wire wherein the first base has a wiring board,the first cell culture container has a first electrode that is embedded in the bottom wall and that is electrically connected to the first culture medium, and a second electrode that extends through a cover member and that is electrically connected to the second culture medium, the first electrode of the first cell culture container is electrically connected to the wiring board due to the first cell culture container being attached to the first base, a first end of the first lead wire is electrically connected to the second electrode of the first cell culture container, and a second end of the first lead wire is electrically connected to the wiring board. (See Nakajami Abstract and Fig. 3 wherein a first electrode 10 is embedded in a bottom wall electrically connected to a first medium and wiring board 14 in the base a second electrode extends through a cover and connected to the second medium. A first end of the first lead wire is electrically connected to the second electrode of the first cell culture container, and a second end of the first lead wire is electrically connected to the wiring board.)
It would have been obvious to one of ordinary skill in the art to provide an electrode arrangement and measurement system as described by Nakajima et al. in the device of Collins because such an electrode arrangement and measurement system allows the noninvasive evaluation of cell cultures as would be desirable in the device of Collins.
Regarding claim 13 Collins discloses all elements above as well as a controller that controls the first pump;(See Collins –[0181]-[0182]) and a transepithelial electrical resistance measurement apparatus that is electrically connected to the wiring board and that measures an electrical resistance value between the first electrode of the first cell culture container and the second electrode of the first cell culture container (See Nakajima [0033]), the above system and all components are placed inside an incubator, i.e. chamber which may be anaerobic.(See Collins Fig. 48 and Allbritton [0103])
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
Prosecution Insights