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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, “the first container” recited in line 26 should read – the first closed container – for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claim 17 recites the limitation "wherein the controller is configured to control the driver to move the cells from the first closed container to the second closed container," however, said limitation constitutes new matter. The instant specification, as originally filed, discloses a controller that moves cell suspension inside stirring part (32) to a closed container (60) (see paragraph [0043]). However, the instant specification is silent regarding a process performed by a controller that moves cell suspension for a first closed container to a second closed container. As such, said limitation constitutes new matter.
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.
Claim 17 is 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.
Claim 17 recites the limitation "wherein the controller is configured to control the driver to move the cells from the first closed container to the second closed container" in lines 8-9. However, the first and second closed containers are not positively recited in the claims and thus the metes and bounds of the claim is unclear.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oda et al. (already of record; JP 2010-142196 ; hereinafter “Oda”) in view of Hampson et al. (already of record; US 2008/0175825; hereinafter “Hampson”) and Shiraiwa (already of record; US 2018/0044624).
Regarding claims 1 and 2, it is noted that while the invention contains closed containers, the closed containers are not positively recited in the instant claim.
Oda discloses a cell culture device, comprising: at least two chambers including a first chamber (FIG. 3: cell culture device (100) includes zone (30) defining a first chamber and comprising a first container (231) capable of culturing cells; [0053]) and a second chamber (FIG. 3: cell culture device (100) includes a second zone (10) defining a second chamber and comprising a second container (210) capable of culturing cells; [0058), wherein the first chamber configured to accommodate at least a first closed container of at least two closed containers (FIG. 3: zone (30) includes at least one container (231)), and the second chamber is configured to accommodate at least a second closed container of the at least two closed containers (FIG. 3: zone (10) includes at least one container (210)); a connection path configured to connect the first closed container and the second closed container accommodated in the first chamber and the second chamber to each other (FIG. 3: supply pipes 240; [0054]-[0057]) and each having an inside kept in an aseptic state (the entire system is in a sterile environment; [0033] and [0076]), each of the first closed container and the second closed container being configured to culture the cells (the first and closed containers of Oda are structurally the same as the instant first and second closed container and thus fully capable of culturing cells); a driver configured to move the cells between the first closed container and the second
closed container via the connection path (FIG. 3: pumps (12A-B) are structurally the same as the instant driver and thus fully capable of moving materials including cells between the first and second closed containers via the connection path; [0057]); and
wherein the driver is configured to move the cells from the first closed container to the
second closed container before the first container is removed, and from the second closed
container to the third container after a third closed container is connected (see FIG. 3: pumps (12A-B) are structurally the same as the instant driver and thus fully capable “to move the cells from the first closed container to the second closed container before the first container is removed, and from the second closed container to a third container after the third closed container is connected”; [0057]). Oda discloses wherein each of the first chamber and second chamber includes an opening (FIG. 3: zones (10,30) each comprising a container therein and thus intrinsically includes an opening). However, Oda does not explicitly disclose wherein the openings include a first opener/closer for the first chamber and a second opener/closer for the second chamber capable of being opened and closed (e.g., door to be opened and closed). Hampson discloses a cell culture device comprising a cassette have a chamber adapted to receive a container (FIG. 5: compartment defined by cassette base 60 and tray 66, and adapted to receive biochamber 10; [0189]), and an opener/closer adapted to cover the compartment (FIG. 5: cover 64; and [0189]). In view of Hampson, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the opener/closer (door/cover) of Hampson with the openings of the first and second chambers of the cell culture device of Oda (i.e., opening of zones (10,30)) for the purpose of covering the contents within the first and second chambers of the cell culture device as disclosed by Hampson ([0189]). Oda discloses wherein the connection path is connected to the at least two containers (e.g., containers 210 and 231; see FIGS. 1-3) but does not explicitly disclose a container attacher/detacher configured to, after the cells are moved from the first closed container to the second closed container by the driver and while the moved cells are cultured in the second closed container: remove the first closed container as a cell movement source from the connection path while maintaining an aseptic state inside the second closed container, to which the cells are moved by the driver, and inside the connection path; and after the first closed container is removed from the connection path, connect a
third closed container, which is configured to culture the cells and is loaded into the first
chamber via the first opener/closer to the connection path while maintaining an aseptic
state inside the third closed container and inside the connection path. Shiraiwa discloses a cell culture device comprising at least one chamber (incubator part 101), a first container (FIG. 4A: cartridge 200; [0080]), a second container (FIG. 4A: cell culture container 75; [0080]), a connection bath configured to connect the first container and second container (FIGS. 9A-B: inflow port (221) and outlet flow part (212) fluidically connects the first container (200) to the second container (75); [0102]-[0103]), and a container attacher/detacher configured to aseptically attach and detach the first container to and from the second container (FIG. 4: conveying part 109 adapted to connect cassette (first container) to the cell culture container 75 (second container), and disconnect and remove the cassette from the cell culture container; [0062], [0080]-[0084], [0102], [0117]). In view of Shiraiwa, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have employed the container attacher/detacher of Shiraiwa with the cell culture device of Oda to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of automating the introduction of containers into and from the cell culture device of Oda, and to provide fresh nutrient/medium to the cell culture container, as disclosed by Shiraiwa ([0062], [0080]-[0084], [0102]-[0103], [0117]). The container attacher/detacher of modified Oda is structurally the same as the instant container attacher/detacher and thus considered to be fully capable of performing the recited functions of “after the cells are moved from the first closed container to the second closed container by the driver and while the moved cells are cultured in the second closed container: remove the first closed container as a cell movement source from the connection path while maintaining an aseptic state inside the second closed container, to which the cells are moved by the driver, and inside the connection path; and after the first closed container is removed from the connection path, connect a
third closed container, which is configured to culture the cells and is loaded into the first
chamber via the first opener/closer to the connection path while maintaining an aseptic
state inside the third closed container and inside the connection path.” Furthermore, it is noted that the recitations of functional language "e.g., for culturing cells in a closed container whose inside is kept in an aseptic state; to move cells between the at least two closed containers via the connection path; to culture the cells" are drawn to intended use of the claimed invention. It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed cell culture device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, modified Oda further discloses wherein the cell culture device further comprises an environment adjuster configured to adjust internal environments of the first chamber and the second chamber (FIG. 3: cooling unit (11) and humidification pan (234); [0040], [0042] and [0049]).
Regarding claim 3, modified Oda further discloses at least one temperature sensor configured to detect temperatures inside the first chamber and the second chamber (environmental conditions are monitored by sensors and adjusted to predetermined values; [0038]-[0041] and [0075]), wherein the environment adjuster is configured to adjust the temperatures inside the first chamber and the second chamber, and wherein the environment adjuster adjusts the temperatures inside the first chamber and the second chamber to predetermined values when the cells are moved through the connection path (environmental conditions are monitored by sensors and adjusted to predetermined values; [0038]-[0041] and [0075]). Furthermore, it is noted that the recitation of functional language "to adjust the temperatures inside the first chamber and the second chamber, and the environment adjustment part adjusts the temperatures inside the first chamber and the second chamber to predetermined values when the cells are moved through the connection path" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed cell culture device and thus since the structure is the same, the claimed functions are apparent.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oda in view of Hampson and Shiraiwa as applied to claim 3 above, and further in view of Pethe (US 2014/0230929).
Regarding claim 17, modified Oda discloses the cell culture device of claim 3 as set forth above. Modified Oda discloses wherein at least temperature sensor is employed with the cell culture device but does not explicitly disclose wherein the at least one temperature sensor includes a first sensor configured to detect a temperature of the first chamber; and a second sensor configured to detect a temperature of the second chamber. Benedict discloses a cell culture device comprising a temperature sensor coupled to a bioreactor and a temperature sensor coupled to a media reservoir (FIG. 1: sensors (106,120); [0046]). In view of Benedict, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell culture device of modified Oda with the cell culture device of Benedict such that each of the chambers comprises a temperature sensor. One of ordinary skill in the art would have made said modification for the purpose of enchanting the detection of temperature changes within the chambers. Modified Oda does not explicitly disclose a controller configured to control the
driver, based on the detected temperatures of the first chamber and the second chamber, to move the cells between the at least two closed containers, and wherein the controller is configured to control the driver to move the cells from the first
closed container to the second closed container, when the detected temperature of the first
chamber is the same as the detected temperature of the second chamber. However, modified Oda does disclose wherein the chambers are maintained at desired temperatures. Pethe discloses a first chamber comprising a first temperature (e.g., see FIG. 1: reservoir 12), a second chamber comprising a second temperature (FIG. 1: bioreactor 12), a pump (28) adapted to move materials between the first and second chambers, and a controller coupled to the first and second chambers (FIG. 1: 21). See paragraphs [0029]-[0035]). The controller is configured to controller the pump based on the temperature detected in the first and second chambers (see, e.g., [0030]-[0035]). The detected temperature of the first chamber and the detected temperature of the second chamber can be the same or different. In view of Pethe, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cell culture device of modified Oda with the cell culture device of Pethe to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of maintaining the temperature of the materials exchanged between the first and second chambers at the desired value.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 have been considered but are moot in view of the new ground of rejection.
In response to the Applicant’s argument that the applied prior art fails to disclose the limitations “after the cells are moved from the first closed container to the second closed container by the driver and while the moved cells are cultured in the second closed container: remove the first closed container as a cell movement source from the connection path while maintaining an aseptic state inside the second closed container, to which the cells are moved by the driver, and inside the connection path; and after the first closed container is removed from the connection path, connect a
third closed container, which is configured to culture the cells and is loaded into the first
chamber via the first opener/closer to the connection path while maintaining an aseptic state inside the third closed container and inside the connection path,” Applicant’s argument is not persuasive because the argument appears to be directed to manner of operating disclosed apparatus. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim. Moreover, while the invention contains cells and closed containers, the cells and the closed containers are not positively recited in the instant claims.
In response the applicant’s argument that in Oda, second chamber (zone 10) cannot be regarded as a cell culturing chamber because the container (210) is maintained at 4°C (see Remarks/Arguments at page 12), Applicant’s argument is not persuasive because Applicant’s distinction appears to be directed to the intended uses of the apparatus. There is nothing in Oda that precludes the zone (10) from being maintained at other temperatures.
In response the applicant’s argument that the exchange of materials between the containers of Oda does not included exchange of cells (see Remarks/Arguments at page 12), again, the cells are not elements of the claimed cell culture device. Rather, they are instead a material upon which the claimed cell culture device is intended to operate during an intended operation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Oda discloses that the containers exchange materials and thus the containers are fully capable of exchanging cells.
Conclusion
No claim is allowed. 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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799