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 .
Applicant's election without traverse of Group I, claims 1-3, 7-9, 14, 16, 18, and 21, and the species of (b) in claim 7, in the reply filed on 6 March 2026 is acknowledged. Upon further search and consideration, the species of claim 7 (a), and corresponding claims 8 and 9, are rejoined and examined on the merits. Claims 16, 18, 19, 21, 23-25, 29-31, 36, 38, 40, and 43, and the species (c)-(e) in claim 7, have been withdrawn.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.
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.
Claims 1-3, 7-9, and 14 are 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.
Regarding claim 1, use of parentheses renders the claim indefinite because it is unclear whether the limitation within the parentheses is part of the claimed invention. As such, it is unclear if the degradation product is intended to be a low molecular weight species, or if this is merely exemplary. For the purposes of examination, the limitation within parentheses is not deemed to be required.
Additionally, the term “high concentration” in claim 1 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Here, it is unclear what concentration of the target protein is intended to be included in, or excluded from, a “high concentration” as currently recited.
Claim 2 recites the limitation "the end of the cell culture" in line 2. There is insufficient antecedent basis for this limitation in the claim. No end of a cell culture is previously recited in the claims. Claim 7 is likewise rejected for recitation of “the end of the cell culture” in (b) and (c).
Claim 3 recites the limitation "the LMWS generated" in line 2. There is insufficient antecedent basis for this limitation in the claim. No amount of LMWS is previously recited as being produced. Additionally, LMWS is a limitation contained within parentheses in claim 1, and is not deemed to be a required component and the method is directed to preventing so the product would not be produced to be generated.
Claims 8, 9, and 14 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
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 at a concentration, which is deemed to be at a “high” concentration, 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 degradation product of a target protein, 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 2, 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 results of the antibody concentration being 4.0 g/L or more at the end of culturing, and 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.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653