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
Newly submitted claims 12-19 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
The inventions of original claim 1-7 and newly submitted claims 12-19 lack unity of invention because even though the inventions of these groups require the technical feature of a cell culture container in an anaerobic chamber with a main body unit and a operation unit, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of the rejection of claim 1 below.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 12-19 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1-4, 8-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Katayama et al. (US 2019/0382703 From IDS) in view of Murthy (US 2022/0169972) and further in view of Nishimura et al. (US 2019/0193287).
Regarding claim 1 Katayama et al. discloses a cell culture system comprising: an anaerobic chamber; a cell culture container disposed in an anaerobic chamber;(See Katayama Abstract and Fig. 1 and [0100] wherein a cell culture container is placed in an anaerobic chamber.)
Katayama also discloses exchanging media, providing specific environments within the cell culture container, and utilizing sensors but does not specifically disclose an external apparatus within the anaerobic chamber to perform a process and wirelessly transmit a signal associated therewith to an operation unit.
Murthy discloses a cell culture system wherein a cell culture device is placed within a chamber and an external apparatus having a main body unit is disposed in the chamber with an operation unit disposed outside the chamber, wherein the main body unit is configured to perform a predetermined process onto the cell culture container, and the operation unit is configured to transmit or receive a signal associated with the predetermined process to or from the main body unit by wireless communication. (See Murthy Abstract and [0069] and Fig. 3 wherein a cell culture container 410 is placed in a chamber, i.e. incubator, 415. An external apparatus with a main body unit, i.e. pump 435 and/or sensors 440, within the chamber is configured to perform a predetermined process onto the culture container, i.e. delivery of materials and sensor use. An operation unit, i.e. controller 405, is wirelessly sends/receives signals associated with the predetermined process.)
It would have been obvious to one of ordinary skill in the art at the time of filling to provide an external controller wirelessly in signal communication with a main body unit including a pump and sensors configured to perform a predetermined process within a culture container as described by Murthy in the system of Katayama because doing so allows for automated control and monitoring of a cell culture system and reduces operator intervention as would be desirable in the system of Katayama.
modified Katayama discloses all the claim limitations as set forth above but does not specifically disclose an insert portion for insertion of a user’s hand.
Nishimura et al. discloses a cell culture system wherein a cell culture device is placed in an chamber and wherein the chamber comprises an insert portion from which an user's hand is to be inserted to allow manipulation and movement of cell culture devices within the chamber. (See Nishimura et al. Abstract [0027],[0031],[0073], [0087] and Fig. 2 wherein an insert portion 11 allows insertion of a user’s hand within a cell culture chamber 2.)
It would have been obvious to one of ordinary skill in the art at the time to provide an insert portion as described by Nishimura in the system of Katayama because doing so allows a user to move and manipulate cell cultures within a chamber and allows maintenance of aseptic conditions within a chamber as would be desirable in the device of modified Katayama.
Regarding claim 2 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein the cell culture container has an oxygen-permeable membrane, a first space, and a second space, the oxygen-permeable membrane being disposed in the cell culture container, the oxygen-permeable membrane including a first main surface and a second main surface opposite to the first main surface, the second main surface being configured for culturing cells, the first space being partially defined by the first main surface and being configured to store a first culture medium, the second space being partially defined by the second main surface and being configured to store a second culture medium having a dissolved oxygen concentration lower than a dissolved oxygen concentration of the first culture medium. (See Katayama [0066]-[0067] and Fig. 1 wherein an oxygen permeable membrane 3 with first, i.e. bottom, and second, i.e. top, surfaces which divides the device into first and second spaces in which various materials may be cultured.)
In regards to specific materials within the device and properties thereof it is noted that such limitations are directed to materials worked on and intended uses of the claimed device which do not define structural elements which differentiate the claimed invention from the cited art. See MPEP 2114 and 2115.
Regarding claim 3 modified Katayama discloses all the claim limitations as set forth above as well as the device the predetermined process is one of replacement of the first culture medium or the second culture medium. (See Murthy [0008], [0059], and [0069] wherein the predetermined process is replacement of culture medium, i.e. it must be first or second culture medium, and/or the process can be measurement of dissolved oxygen concentration of the medium.)
Regarding claim 4 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein the wireless communication is performed by communication in compliance with WiFi or Bluetooth. (See Murthy [0069] wherein the wireless communication is via Bluetooth.)
Regarding claim 8 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein the process is measurement of an electrical resistance value of the cells cultured on the second main surface of the oxygen- permeable membrane. (See Katayama [0110] wherein an electrode is placed to measure an electrical resistance of the cells cultured on the second main surface.)
Regarding claim 9 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein the external apparatus is an electrical resistance measurement apparatus which includes an electrode. (See Katayama [0110] wherein an electrode is placed to measure an electrical resistance of the cells cultured on the second main surface.)
Regarding claim 11 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein the process is measurement of the dissolved oxygen concentration of the first culture medium or measurement of the dissolved oxygen concentration of the second culture medium. (See Rejection above wherein the sensors communicate by sending signals to the controller and Katayama [0183] and dissolved oxygen of the first and or second culture medium is measured.)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Katayama et al. (US 2019/0382703 From IDS) in view of Murthy (US 2022/0169972) and Nishimura et al. (US 2019/0193287) as applied to claims above, and further in view of Nakajima et al. (US 2014/0045252).
Regarding claim 10 modified Katayama discloses all the claim limitations as set forth above as well as the device wherein transepithelial electrical resistance is measured by utilizing electrodes with measure resistance but does not specific the placement of said electrodes.
Nakajima et al. discloses a cell culture system with a cell culture container and an electrical resistance measurement apparatus for measuring transepithelial electrical resistance by utilizing is a first electrode; and a second electrode;the first electrode extends through a container main body of the cell culture container and into the first space; the second electrode extends through a cover member of the cell culture container and into the second space; and the container main body of the cell culture container and the cover member of the cell culture container are on opposite sides of the cell culture container, respectively. (See Nakajima Abstract and Figs. 6-8 wherien a cell culture container has a first electrode 15 extending through a main body thereof and a second electrode 11 extending through a lid such that they are on opposite sides of the cell culture container.)
It would have been obvious to one of ordinary skill in the art at the time of invention to utilize an electrical measurement system with electrode placement as described by Nakajima in the device of modified Katayama because it represents a specific system for use in cell culture devices and allows maintaining a closed system and observation of the device during measuring as would be desirable in the device of modified Katayama.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Applicant argues “It is respectfully submitted that it would have been nonobvious to modify the combined culture system of Katayama/Murthy so as to incorporate an insert portion.
If the culture system of Katayama were modified so as to have the external controller 405 of Murthy, then the culture tank 1 of Katayama, which is disposed in the anaerobic chamber, would be in wireless communication with the external controller 405 of Murthy, which is disposed outside the anaerobic chamber. Consequently, the combined culture system of Katayama/Murthy does not require any insert portion in order for the culture tank 1 to be functional.
Nishimura generally teaches a main isolator 2 which includes an aseptic air supply means to aseptically maintain a work space W inside, and a transparent window 2a positioned on the front side and provided with a glove 11 to be worn by a worker when working in the work space W (see, e.g., Nishimura FIGs.1A-2 and 0027).
However, there is no teaching, suggestion or motivation to further combine the glove 11 of Nishimura with the combined culture system of Katayama/Murthy. “
It is noted that the examiner disagrees with applicant that there is no teaching, suggestion, or motivation to combine a glove insert in the system of Katayama/Murthy. The examiner specifically pointed out in the rejection that Nishimura notes that such a glove portion allows one to perform any desired task and move a cell culture device in an aseptic manner. This would be desirable in the device of Katayama/Murthy. While Katayama/Murthy discloses a controller on the outside that allows some tasks to be completed, i.e. pumping and sensor data receiving, it does not allow movement, visual inspection, pipette sampling, and numerous other tasks which one may deem desirable or necessary in any given cell culture experiment. As such one of ordinary skill in the art at the time of filing would have been motivated to provide such an insert portion.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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