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 without traverse of Group II, claims1, 3 and 8 – 11 in the reply filed on June 11, 2025 is acknowledged. Applicant elected naphthoresorcinal as the aromatic compound.
Claims 1 – 16 are pending; claims 2, 4 – 7 and 12 – 16 are withdrawn; claims 1, 3 and 8 – 11 have been considered insofar as they read on the elected invention.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 23, 2022; October 19, 2023; and July 14, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 and 8 – 11 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.
Claims 1, 3 and their dependents are drawn to a method of evaluating a cell containing suspension, however are rendered 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. The recitation of “using” a mixture of a cell suspension and an aromatic compound does not set forth any active or specific steps such that one would know the metes and bounds of the claims.
In claims 8 and 9, line 9, “reaction product” is not adequately defined by the claim language or specification. It is unclear what is being quantified as no clear reaction or product is identified such that one would know the scope of the claims.
Claim 9 is confusing as it appears to require components that are not identified in previous claims. Specifically, “mass of saccharides” and “hydrolysis of the support” lack proper antecedent basis as these phrases suggest a particular material must be used for the cell support and that an active step of hydrolysis has occurred. The claim is further confusing as it is unclear what the last two lined intends to encompass. The language appears to be a non sequitur as it does not specifically relate to the “method.”
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102a1 as being anticipated by Kim et al. (IDS 10.19.2023 NPL #8).
Regarding claims 1 and 3, Kim teaches a method of evaluating tissue/cell scaffolding degradation (a method of evaluating a sample) using near infrared (NIR) fluorescence imaging (abstract), wherein the method uses a mixture of ECM from porcine small intestinal submucosa (a dissolvable scaffold) and ZW800-1 N-hydroxysuccinimide (NHS) ester (an aromatic compound with a functional carbonyl group) (p.2). Kim quantifies the scaffold degradation in vivo, wherein the mixture effectively includes the dissolvable scaffold, aromatic compound and cells (p.3). The method further comprises fluorescence analysis (p.2).
The reference anticipates the claimed subject matter.
No claims are allowed.
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