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 .
Applicant's amendment filed April 17, 2026 and the reply filed November 25, 2025 have been received and entered into the case. Claims 1 - 2, 4 - 7, 9 - 17 and 20 are pending; claims 2, 4 - 7, 12 - 16 are withdrawn; claims 1, 9 - 11, 17 and 20 have been considered on the merits. All arguments have been fully considered.
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 and 8 – 11 remain 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.
Claims 1 and its dependents are drawn to a method of evaluating a cell containing suspension, however remain indefinite because the claims fail to set forth any positive steps of evaluation. The claims fail to indicate what characteristic or parameter is being evaluated and what steps must be carried out. While steps are recited to prepare the sample, heat the sample and run generic fluorescence or absorption analysis, no active steps are recited for any particular evaluation or analysis. Moreover, the scope of the claim remains unclear as for what qualities the sample is being evaluated, assessed or judged. Applicant may overcome this rejection by amending the preamble to "A method for measuring cell support derived components in a sample".
In claim 9, “reaction product” remains indefinite as it remains unclear what the reaction product is required to be and from where the reaction product forms. Moreover, it remains unclear what is quantified.
Claim 9 remains indefinite for reciting "a mass of saccharides produced by acid hydrolysis" because the phrase lacks proper antecedent basis. The claim on which it depends does not require an active step of acid hydrolysis. Moreover, it is unclear if active steps of acid hydrolysis are required to be carried out or if the limitation is merely further defining a process by which the sample (cell suspension containing cells) is obtained.
Response to Arguments
Applicant argues that active steps are recited and the claims are clear.
However, this argument fails to persuade for the reasons iterated above.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 as being anticipated by Kim et al. (IDS 10.19.2023 NPL #8) are withdrawn.
Applicant argues that Kim does not teach the method wherein the cell suspension containing cells is obtained after culturing the cells in the presence of a polysaccharide cell support and performing acid hydrolysis on the support.
This argument is persuasive. The prior art teaches methods for analyzing cell samples for scaffolding degradation via fluorescence analysis wherein the scaffold is a biodegradable protein. However, the prior art does not teach or suggest performing an acid hydrolysis on a polysaccharide support and then collecting the cell suspension containing cells, combining with an acid and naphthoresorcinol, followed by heating prior to analysis.
No claims are allowed.
Conclusion
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699