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, claims 1-11, in the reply filed on 12/10/2025 is acknowledged.
Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/19/2023, 10/18/2023, and 01/018/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 3 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 3 recites “a first buffer transfer conduit configured to transfer the buffer solution from the treatment tank to the removal member; and a second buffer transfer conduit configured to transfer the buffer solution from the removal member to the treatment tank”, and this limitation is indefinite as it appears to be inconsistent with what is described in the specification. The specification states that “The buffer delivery conduits 232 and 233 may connect the buffer tank 231 and a plurality of dialysis tubes 2353” (see para. 37) and thus it is understood that the buffer transfer conduits connect the removal member to the buffer tank rather than the treatment tank. Additionally, only a connection to the buffer tank (231) is shown in Fig. 1 and it is unclear from this Figure and the Figures as a whole how the buffer transfer conduits (232, 233) could transfer buffer from the treatment tank (21) rather than the buffer tank.
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.
Claims 1, 4 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konishi et al. (US Patent Application Publication 2016/0355774).
Regarding claim 1, Konishi et al. discloses a cell culturing system (para. 38) comprising a cell culturing device controllable by a control device (para. 93-97) (thus the system reads on a bioreactor system), comprising:
a bioreaction unit (comprising culturing device 5, reads on a bioreaction unit) (para. 40) configured to accommodate a culture medium (para. 40-41); and
a treatment unit (comprising component-controlling solution tank 3, feed circuit 7, and membrane 13) configured to recycle the culture medium transferred from the bioreaction unit (para. 40-42, 59),
wherein the treatment unit comprises:
a treatment tank (component-controlling solution tank 3) configured to accommodate the culture medium transferred from the bioreaction unit (para. 40);
a culture medium exchange part (comprising feed circuit 7) configured to exchange the culture medium between the bioreaction unit and the treatment tank (para. 40, 59); and
a waste product removal part (comprising culture solution component-controlling membrane 13) configured to remove waste products contained in the culture medium accommodated in the treatment tank (para. 42, 46).
Regarding claim 4, Konishi et al. discloses wherein the bioreaction unit comprises:
a reaction tank (15) configured to accommodate the culture medium (para. 49-50), and
the culture medium exchange part comprises a first exchange conduit (9) configured to transfer the culture medium from the treatment tank (3) to the reaction tank (15) (para. 59), a second exchange conduit (8) configured to transfer the culture medium from the reaction tank (15) to the treatment tank (3) (para. 59), and an exchange pump disposed in the first exchange conduit to pump the culture medium (para. 41).
Regarding claim 10, Konishi et al. discloses wherein the treatment unit further comprises an aeration part configured to provide air to the culture medium accommodated in the treatment tank (para. 48).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al. (US Patent Application Publication 2016/0355774) in view of Stumpf et al. (US Patent 4,240,912).
Regarding claim 2, Konishi et al. discloses the waste product removal part, as set forth above, wherein the waste product removal part comprises a semipermeable dialysis membrane tube (reads on a removal module) positioned in the treatment tank so that that culture medium flows through the membrane tube and waste products are transferred from the cultured medium to outside the tube (para. 46, 99).
Konishi et al. is silent as to a buffer tank configured to accommodate a buffer solution, and the waste removal module being partially positioned in the treatment tank so that the buffer solution accommodated in the buffer tank is circulated through inside of the removal module and the waste products are transferred from the culture medium accommodated in the treatment tank to the buffer solution.
Stumpf et al. discloses an “immersion dialyzer” configured to operate such that it is “immersed directly into the medium to be dialyzed” (Abstract, col. 1 lines 6-8), rather than the traditional operation of the medium to be dialyzed flowing within a membrane tube as in the invention of Konishi et al. Further, Stumpf et al. discloses wherein the dialyzer comprises a dialysis membrane (8) positioned within the medium in a fermenter bypass, a first buffer transfer conduit extending out of the bypass and configured to transfer dialysis buffer solution from a buffer source to a chamber under the membrane, and a second buffer transfer conduit extending out of the bypass and configured to transfer the buffer solution from the chamber back to the buffer source (col. 3 lines 6-30) (Fig. 1, sheet 1 of 3), such that buffer solution is circulated through inside of the dialyzer and metabolites are transferred from the medium accommodated in the fermenter bypass to the buffer solution (col. 3 lines 6-40).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the waste product removal part disclosed by Konishi et al. to include an immersion dialyzer at least partially immersed in the treatment tank (i.e., comprising a buffer tank configured to accommodate a buffer solution, and a removal module comprising the semipermeable dialysis membrane positioned in the treatment tank and first and second buffer transfer conduits configured to circulate the buffer solution inside the removal module such that waste products are transferred from the culture medium accommodated in the treatment tank to the buffer solution, as in the configuration of Stumpf et al.), as such a modification represents simple substitution of one known element for another to obtain predictable results (MPEP § 2143), in this case, substituting an immersion dialyzer for a traditional dialyzer to dialyze culture medium components.
Regarding claim 3, Konishi et al. in view of Stumpf et al. teaches the removal member, first buffer transfer conduit, and second buffer transfer conduit, as set forth in the rejection of claim 2, above.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al. (US Patent Application Publication 2016/0355774) in view of Smith et al. (US Patent Application Publication 2006/0019385).
Regarding claim 5, Konishi et al. discloses wherein the bioreaction unit further comprises an agitator configured to stir the culture medium accommodated in the reaction tank (para. 97), and a gas inlet part configured to introduce a gas into the reaction tank (para. 97), and
the bioreactor system further comprises a control device electrically connected to the bioreaction unit (para. 92-93, 97),
wherein the control device operates the gas inlet part and the agitator (thus the control device is fully capable of operating the gas inlet part after stopping the operation of the agitator) (para. 92-93, 97) such that the culture medium moves through the second exchange conduit (para. 59, 98-104).
Konishi et al. does not expressly teach wherein the control device comprises a processor, and although Konishi et al. discloses wherein the culture medium exchange part is controlled (para. 101-104), Konishi et al. does not expressly teach the control device being electrically connected to the culture medium exchange part.
Smith et al. discloses a bioreactor system (para. 5) comprising an external flow circuit such that culture medium flows out of a bioreactor to a waste removal component and is subsequently returned to the bioreactor (para. 5, 27, 113) (Fig. 1, sheet 1 of 11). The bioreactor system comprises a processor (para. 62) electrically connected to the bioreactor (para. 88) (Fig. 10, sheet 10 of 11) and the flow circuit (para. 115).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the control device disclosed by Konishi et al. to comprise a processor, wherein the processor is further electrically connected to the culture medium exchange part, based on the teachings of Smith et al., as the skilled artisan would have been motivated to use a control configuration recognized in the art to be suitable for controlling both bioreactor conditions and external flow conditions in order to gain finer control over system operations.
Regarding claim 6, Konishi et al. discloses wherein the control device is configured to operate the gas inlet part and the agitator (thus the control device is fully capable of operating the gas inlet part after a predetermined waiting time passes after stopping the operation of the agitator), and Konishi et al. in view of Smith et al. teaches wherein the control device comprises a processor, as set forth above; therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 7, Konishi et al. discloses wherein the culture medium exchange part comprises the second exchange circuit, as set forth above.
Konishi et al. is silent as to an exchange valve disposed in the second exchange circuit to control the opening and closing of the second exchange circuit.
Smith et al. discloses a bioreactor system (para. 5) comprising an external flow circuit such that culture medium flows out of a bioreactor to a waste removal component and is subsequently returned to the bioreactor (para. 5, 27, 113) (Fig. 1, sheet 1 of 11). Smith et al. further discloses wherein a flow conduit conducting culture medium from the bioreactor to the waste removal component comprises a valve to control opening and closing of the conduit and to allow additional components to be added to the system (para. 115) (Fig. 1, sheet 1 of 11).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the culture medium exchange part disclosed by Konishi et al. to comprise an exchange valve disposed in the second exchange conduit to control opening and closing of the second exchange conduit, as taught by Smith et al., in order to allow for greater control over flow through the conduit and the introduction of additional culture components.
Regarding claim 8, Konishi et al. discloses wherein the bioreaction unit comprises a reaction tank (15) configured to accommodate the culture medium (para. 49-50), and a pH obtaining part configured to obtain a pH of the culture medium accommodated in the reaction tank (para. 97),
the bioreactor system further comprises a control device electrically connected to the bioreaction unit (para. 92-93, 97),
wherein the control device controls system operation on the basis of the pH value obtained by the pH obtaining part (para. 93).
Konishi et al. does not expressly teach wherein the control device comprises a processor, and is silent as to the process being electrically connected to the treatment unit wherein the processor controls the operation of the culture medium exchange part or the waste product removal part on the basis of the pH value obtained by the pH obtaining part.
Smith et al. discloses a bioreactor system (para. 5) comprising an external flow circuit such that culture medium flows out of a bioreactor to a waste removal component and is subsequently returned to the bioreactor (para. 5, 27, 113) (Fig. 1, sheet 1 of 11). The bioreactor system comprises a processor (para. 62) electrically connected to the bioreactor (para. 88) (Fig. 10, sheet 10 of 11) and the waste removal component (para. 124), wherein the processor controls the operation of the waste removal component on the basis of a pH value of culture medium obtained by a pH obtaining part (para. 124).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the control device disclosed by Konishi et al. to comprise a processor, wherein the processor is further electrically connected to the treatment unit wherein the processor controls the operation of the waste product removal part on the basis of the pH value obtained by the pH obtaining part, based on the teachings of Smith et al., as the skilled artisan would have been motivated to use a control configuration recognized in the art to be suitable for controlling both bioreactor conditions and waste removal conditions in order to gain finer control over system operations.
Regarding claim 9, Konishi et al. discloses wherein the bioreaction unit comprises a reaction tank (15) configured to accommodate the culture medium (para. 49-50), and an oxygen amount obtaining part configured to obtain a dissolved oxygen amount of the culture medium accommodated in the reaction tank (para. 97),
the bioreactor system further comprises a control device electrically connected to the bioreaction unit (para. 92-93, 97),
wherein the control device controls system operation on the basis of the dissolved oxygen amount obtained by the oxygen amount obtaining part (para. 93).
Konishi et al. does not expressly teach wherein the control device comprises a processor, and is silent as to the process being electrically connected to the treatment unit wherein the processor controls the operation of the culture medium exchange part or the waste product removal part on the basis of the dissolved oxygen amount value obtained by the oxygen amount obtaining part.
Smith et al. discloses a bioreactor system (para. 5) comprising an external flow circuit such that culture medium flows out of a bioreactor to a waste removal component and is subsequently returned to the bioreactor (para. 5, 27, 113) (Fig. 1, sheet 1 of 11). The bioreactor system comprises a processor (para. 62) electrically connected to the bioreactor (para. 88) (Fig. 10, sheet 10 of 11) and the waste removal component (para. 124), wherein the processor controls the operation of the flow circuit on the basis of the dissolved oxygen amount obtained by an oxygen amount obtaining part (para. 62-63).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the control device disclosed by Konishi et al. to comprise a processor, wherein the processor is further electrically connected to the treatment unit wherein the processor controls the operation the culture medium exchange part on the basis of the dissolved oxygen amount value obtained by the oxygen amount obtaining part, based on the teachings of Smith et al., as the skilled artisan would have been motivated to use a control configuration recognized in the art to be suitable for controlling both bioreactor conditions and culture medium composition conditions in order to gain finer control over system operations.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al. (US Patent Application Publication 2016/0355774) in view of Karnieli et al. (US Patent Application Publication 2022/0204905).
Regarding claim 11, Konishi et al. discloses wherein the bioreaction unit comprises an outlet for drawing culture medium out of the bioreaction unit (para. 41). In operation, culture medium is withdrawn from the bioreaction unit for further analysis (para. 104-108).
Konishi et al. is silent as to a harvesting unit connected to the bioreaction unit to receive the culture medium accommodated in the bioreaction unit.
Karnieli et al. discloses a bioreactor system (Abstract, para. 93) comprising a bioreactor and a (510) (para. 349) and a harvesting unit (511) connected to the bioreactor to receive culture medium accommodated in the bioreactor (para. 349).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system disclosed by Konishi et al. to comprise a harvesting unit connected to the bioreaction unit to receive the culture medium accommodated in the bioreaction unit, based on the teachings of Karnieli et al., in order to provide a mechanism for collecting processed cell culture medium for further analysis.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Coty (US Patent 3,418,208) is directed to a cell culture system comprising a fermenter connected by a fluid line to a treatment tank comprising a dialysis membrane therein for recycling cell culture medium back to the fermenter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799