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, claims 1-5, 7-9, 13-20, 22, 25-27 and 31 in the reply filed on 4/13/2026 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)).
Claims 32-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/13/2026.
Claims 1-5, 7-9, 13-20, 22, 25-27 and 31 are examined in the instant application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 1-5, 8, 13-20, 25-27 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (2007, Biotechnol. Prog., Vol. 23, pgs. 1186-1197).
Regarding claims 1, 15, 16, 18-20 and 31, Kim et al. teach a method for culturing recombinant CHO cells or generating a culture of mammalian cells to produce a recombinant antibody comprising:
(a) placing a plurality of mammalian cells and a volume of culture medium in a culture vessel to generate a cell culture;
(b) culturing the cell culture to a cell density of greater than or equal to 1% packed cell volume (PCV);
(c) conducting a perfusion procedure on the cell culture during step (b), wherein the perfusion procedure comprises:
(i) transferring at least a portion of the cell culture to a continuous flow centrifuge;
(ii) operating the continuous flow centrifuge to generate a solids phase having a cell density of greater than or equal to 1% PCV; and
(iii) returning the solids phase and a volume of cell culture medium to the culture vessel to achieve a perfusion rate that ranges from 0.7 to 6 vessel volumes per day (VVD), wherein following completion of the perfusion procedure, the cell culture has a cell density of 0.2% PCV or greater (see Abstract,).
Regarding claim 2, Kim teaches perfusion rate changes from 2 to 6 VVD (pg. 1189).
Regarding claims 3 and 4, Kim teaches that the perfusion rate can be at a constant or variable (pg. 1189-1191).
Regarding claim 5, Kim teaches that the perfusion procedure was conducted continuously over a time period from 1 to 7 days (Fig. 4).
Regarding claim 8, Kim used a tubular bowl (pg. 1188 col. 1 parag. 3 and Fig. 1).
Regarding claims 13 and 14, Kim teaches a viability percentage of greater than or equal to 85% over 1 to 7 days (pg. 1190 col. 2 parag. 2).
Regarding claim 17, Kim teaches that the lactate concentration was less than or equal to 4 g/L (pg. 1189, col. 2 parag. 1).
Regarding claim 25, Kim teaches transferring at least a portion of the cell culture to a different culture vessel to initiate a second cell culture (Fig. 1).
Regarding claims 26 and 27, Kim teaches a second cell culture has an initial cell density that ranges from 0.1% to 10% (see Abstract and Fig. 6).
Thus, Kim clearly anticipates the invention of claims 1-5, 8, 13-20, 25-27 and 31.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 7 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (2007, Biotechnol. Prog., Vol. 23, pgs. 1186-1197) in view of Kompala DS. (US Pat. No. 10,596,492 B2, issued 3/24/2020).
Regarding claim 1, Kim et al. teach a method for culturing recombinant CHO cells or generating a culture of mammalian cells to produce a recombinant antibody comprising:
(a) placing a plurality of mammalian cells and a volume of culture medium in a culture vessel to generate a cell culture;
(b) culturing the cell culture to a cell density of greater than or equal to 1% packed cell volume (PCV);
(c) conducting a perfusion procedure on the cell culture during step (b), wherein the perfusion procedure comprises:
(i) transferring at least a portion of the cell culture to a continuous flow centrifuge;
(ii) operating the continuous flow centrifuge to generate a solids phase having a cell density of greater than or equal to 1% PCV; and
(iii) returning the solids phase and a volume of cell culture medium to the culture vessel to achieve a perfusion rate that ranges from 0.7 to 6 vessel volumes per day (VVD), wherein following completion of the perfusion procedure, the cell culture has a cell density of 0.2% PCV or greater (see Abstract,).
Kim does not teach:
A disc stack bowl centrifuge (aka a conical centrifuge).
Regarding a conical centrifuge in claim 7, Kompala DS. teaches using a conical
centrifuge for use in a perfusion bioreactor to produce a protein in CHO cells (Fig. 20, col. 2 lines 9-33 and col. 15 lines 6-22).
Kompala continues to teach that using a conical surface can improve cell viability and productivity (col. 22 lines 15-31).
Regarding claim 22, Kompala teaches that volume can be greater than 20,000L in their perfusion bioreactor (col. 31 lines 8-26).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Kim regarding a method for culturing CHO cells using a perfusion culture with the teachings of Kompala regarding using a conical centrifuge in a bioreactor to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Kompala teaches that using a conical surface can improve cell viability and productivity.
There would have been a reasonable expectation of success that the conical centrifuge of Kompala would work in the method of Kim since Kompala teaches using the same species of cell, CHO cells.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (2007, Biotechnol. Prog., Vol. 23, pgs. 1186-1197) in view of Pham CY. (US Pat. No. 7,759,117 B2, issued 7/20/2010).
Regarding claim 1, Kim et al. teach a method for culturing recombinant CHO cells or generating a culture of mammalian cells to produce a recombinant antibody comprising:
(a) placing a plurality of mammalian cells and a volume of culture medium in a culture vessel to generate a cell culture;
(b) culturing the cell culture to a cell density of greater than or equal to 1% packed cell volume (PCV);
(c) conducting a perfusion procedure on the cell culture during step (b), wherein the perfusion procedure comprises:
(i) transferring at least a portion of the cell culture to a continuous flow centrifuge;
(ii) operating the continuous flow centrifuge to generate a solids phase having a cell density of greater than or equal to 1% PCV; and
(iii) returning the solids phase and a volume of cell culture medium to the culture vessel to achieve a perfusion rate that ranges from 0.7 to 6 vessel volumes per day (VVD), wherein following completion of the perfusion procedure, the cell culture has a cell density of 0.2% PCV or greater (see Abstract,).
Kim does not teach:
an operating speed of 3,000 to 10,000 RPM.
Regarding an operating speed of 3,000 to 10,000 RPM in claim 9, Pham CY.
teaches using a bioreactor with a disk stack bowl to produce an antibody of interest at 10,000 RPM in CHO cells (Examples 1-2).
Pham continues to teach that high centrifuge speeds can improve settling (col. 4
lines 57-67).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Kim regarding a method for culturing CHO cells using a perfusion culture with the teachings of Pham regarding using a centrifuge at 10,000 RPM in a bioreactor to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Pham teaches that high centrifuge speeds can improve settling.
There would have been a reasonable expectation of success that the 10,00 RPM would work in the method of Kim since Pham teaches using the same species of cell, CHO cells.
Thus, the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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, Peter Paras can be reached at 571-272-4517. 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.
/DAVID A MONTANARI/Examiner, Art Unit 1632
Prosecution Insights