DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 17 July 2026. Claims 1, 3, and 7 have been amended. Claim 2 has been cancelled. Claims 16, 18, 19, 21, 23-25, 29-31, 36, 38, 40, and 43, and the species (c)-(e) in claim 7, remain withdrawn. Claims 1, 3, 7-9, and 14 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/JP2022/018636, filed 22 April 2022, which claims priority to Japanese Patent Document No. JP2021-073666, filed 23 April 2021.
Withdrawal of Rejections:
The rejection of claims 1-3, 7-9, and 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification of Rejections Necessitated by Amendment:
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, 3, 7-9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toronjo-Urquiza et al. (Screening Naturally Occurring Phenolic Antioxidants for Their Suitability as Additives to CHO Cell Culture Media Used to Produce Monoclonal Antibodies, Antioxidants, Vol. 8, Iss. 159, (2019), pp. 1-18 – Previously Presented).
With regard to claims 1 and 3, Toronjo-Urquiza et al. teach producing monoclonal antibodies, which are a target protein, in a culture medium where antioxidants including catechin and catechin analogues, including epigallocatechin gallate, are added to the culture medium, thus removing a reactive oxygen species from the culture medium and producing the target protein, which is an antibody, in the culture medium during culturing (Abs.; p. 11, para. 1; Figs.: 2B, 3B, 4B, 5B, 6B, 7B).
Toronjo-Urquiza et al. teach the steps of the method as claimed, including the components as claimed. As such, the results of preventing generation of a low molecular weight species (LMWS) of a target protein; the antibody concentration being 4.0 g/L or more in the culture medium at the end of culturing; and reducing an amount of LMWS generated as compared with a cell culture process not including the removing of the reactive oxygen species, would naturally flow from performance of the taught method.
With regard to claims 7 and 14, Toronjo-Urquiza et al. teach adding an antioxidant to the culture medium (Abs.; Fig. 4B). Additionally, Toronjo-Urquiza et al. teach producing tissue plasminogen factor, which is a target protein, in a culture medium where reduced glutathione, which is a cystine analogue, is added to the culture medium, thus removing a reactive oxygen species from the culture medium and producing the target protein at a concentration, which is deemed to be at a “high” concentration, in the culture medium during culturing (p. 10, 4. Discussion, para. 1). Toronjo-Urquiza et al. teach the steps of the method as claimed, including the components as claimed. As such, the results of the cystine analogue having a concentration of 1.9 mmol/L or less, or between 0.5-1.9 mmol/L at the end of culturing, would naturally flow from performance of the taught method.
With regard to claims 8 and 9, Toronjo-Urquiza et al. teach producing monoclonal antibodies in a culture medium with catechin analogues, including epigallocatechin gallate, at amounts including 50 µM, 75 µM, 100 µM (Abs.; Fig. 3B). Toronjo-Urquiza et al. teach the steps of the method as claimed, including the components as claimed. As such, the result of the catechin analogue having a concentration of 50 µmol/L or more at the end of culturing, would naturally flow from performance of the taught method.
Response to Arguments
Applicant urges that the cited art fails to disclose the technical feature that the antibody concentration in the culture medium at the end of the cell culture process is 4.0 g/l or more. Instead, Toronjo-Urquiza merely evaluates the effect on cells of removing ROS by an antioxidant, such as viability and productivity per cell. The cited document does not teach or suggest degradation products, and the concentration of the antibody produced under the condition of the cited document is as low as about 10 µg/mL (10 mg/L).
Applicant’s arguments have been fully considered but have not been found persuasive. Toronjo-Urquiza et al. teach the steps of the method as claimed, including the components as claimed, which include: producing an antibody in a culture medium during a cell culture process, and removing a ROS in the culture medium during the cell culture process. As such, the results of preventing generation of a LMWS of a target protein; and the antibody concentration being 4.0 g/L or more in the culture medium at the end of culturing, would naturally flow from performance of the taught method. Absent an essential step or feature missing from the claims, the same components used in the same method steps necessarily must be capable of providing the same result.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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