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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/17/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13 and 17-20 in the reply filed on 11/03/2025 is acknowledged.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/03/2025.
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 4, 10-12 and 17 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.
Claim 4 recites the limitation “the cellular compartment” in line 4 and “the culture medium compartment” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase similar renders the claim indefinite because it is unclear what applicant intended to cover by the recitation “similar”. See MPEP § 2173.05(b).
Claim 12 recites the limitation “the plurality of runs” in lines 1-2 and “the plurality of training runs” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claims 11 and 17 are dependent on claim 10 and are therefore, rejected for the same reason.
Allowable Subject Matter
Claims 1-3, 5-9, 13 and 18-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closets prior art of record is GAO JINXIN ET AL: "Multivariate analysis of cell culture bioprocess data", AMERICAN PHARMACEUTICAL REVIEW, vol. 23, no. 3, 1 April 2020 (2020-04-01), pages 78-81 and Wolfgang et al. WO 2019/129891 A1 (cited in the IDS filed 03/17/2023). Gao teaches obtaining measurements, using a pre-trained multivariate model to determine the value of one or more latent variables, comparing the values of the one or more latent variables to one or more predetermined values as a function of maturity and determining on the basis of the comparison whether the bioprocess is operating normally. Gao does not suggest determining one or more metabolic condition variables and using the metabolic variable conditions as predictor variables to monitor the current state of a bioprocess. Wolfgang et al. uses predicted future metabolic states as indications of the state of the bioprocess, which provides a different approach to bioprocess monitoring than Gao and the instant invention.
The international search report, opposition decision and the references cited therein were fully reviewed. The prior art fails to teach or suggest the instant claims.
Conclusion
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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