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 I (claims 1-7 and 10); and species A, 1; B, 1 and C, 1 in the reply filed on 08/20/2026 is acknowledged.
Claims 1-3, 5, and 7 are being examined.
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, 5, and 7 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 1 is unclear reciting “[...] using, as an index, [...]” because it is unclear what this step entails. Claim 1 is also unclear because it is ambiguous whether “light-absorption/fluorescence” refers to light-absorption and fluorescence, light-absorption or fluorescence, or light-absorption and/or fluorescence.
Claim 2 is unclear in reciting “wherein the aggregation state is evaluated based on a relationship between a time from when the aggregative proteins are brought into an aggregatable state in the solution, and the light-absorption/fluorescence characteristic(s) of the xanthene dye.” Specifically, the claim appears to define a result to be achieved without reciting the necessary method steps. In addition, the term “aggregatable state” is not clearly defined in the claim, rendering the claim indefinite.
Claim 7 is unclear reciting “wherein the aggregation state of the aggregative proteins is evaluated based on a relationship in which a maximum fluorescence intensity or a fluorescence intensity at a predetermined fluorescence wavelength decreases and thereafter increases with respect to a time from when the aggregative proteins are brought into an aggregatable state in the solution, the predetermined fluorescence wavelength being a wavelength which can be determined depending on the xanthene dye and the aggregative proteins.” Specifically, the claim appears to define a result to be achieved without reciting the necessary method steps. In addition, the phrase “the predetermined fluorescence wavelength being a wavelength which can be determined depending on the xanthene dye and the aggregative proteins” renders the claim indefinite because it is unclear what specific method step is being claimed.
A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
Claim(s) 1-3, 5, and 7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Lee et al. (Photo-induced inhibition of Alzheimer's β-amyloid aggregation in vitro by rose bengal, Biomaterials, Volume 38, 2015, Pages 43-49).
Regarding claim 1, Lee teaches:
1. A method for evaluating an aggregation state of aggregative proteins in a solution, the method comprising
evaluating an aggregation state of aggregative proteins (see the abnormal aggregation of β-amyloid (Aβ) peptides, Abstract+) using light-absorption/fluorescence characteristic(s) of a xanthene dye in a solution comprising the aggregative proteins and the xanthene dye or a salt thereof (see i.e., We report on visible light-induced inhibition of Aβ aggregation by xanthene dyes, which are widely used as biomolecule tracers and imaging markers for live cells. Among many xanthene dyes, rose bengal (RB) under green LED illumination exhibited a much stronger inhibition effect upon photo-excitation on Aβ aggregation than RB under dark conditions. We found that RB possesses high binding affinity to Aβ; it exhibits a remarkable red shift and a strong enhancement of fluorescence emission in the presence of Aβ. Photo-excited RB interfered with an early step in the pathway of Aβ self-assembly and suppressed the conformational transition of Aβ monomers into β-sheet-rich structures. Photo-excited RB is not only effective in the inhibition of Aβ aggregation, but also in the reduction of Aβ-induced cytotoxicity. Abstract),
wherein the xanthene dye is represented by Formula (I):
PNG
media_image1.png
528
717
media_image1.png
Greyscale
wherein X1 to X4 are each independently -H, -OH, -NO2, -F, -Cl, -Br, or -I, provided that at least one of X1 to X4 is -Br or -I; and Y1 to Y4 are each independently -H, -F, or -Cl (e.g., rose bengal (RB), erythrosine B, eosin Y, phloxine B, etc. P45/3.1. Screening of xanthene dyes under dark for inhibition of Aβ aggregation).
Regarding claims 2, 3, 5 & 7, Lee teaches:
2. The method according to claim 1, wherein the aggregation state is evaluated based on a relationship between a time from when the aggregative proteins are brought into an aggregatable state in the solution, and the light-absorption/fluorescence characteristic(s) of the xanthene dye (see P45+/3. Results and discussion & Figs. 1-3).
3. The method according to claim 1, wherein X1 to X4 are each independently -H, -OH, -NO2, -F, -Cl, -Br, or -I, provided that at least two of X1 to X4 are -Br or -I; and Y1 to Y4 are each independently -H or -Cl (e.g., rose bengal (RB), erythrosine B, eosin Y, phloxine B, P45/3.1. Screening of xanthene dyes under dark for inhibition of Aβ aggregation).
5. The method according to claim 1, wherein the light-absorption/fluorescence characteristic(s) includes at least one selected from the group consisting of a fluorescence spectrum, a fluorescence intensity, a maximum fluorescence wavelength, an absorption spectrum, an absorbance, and a maximum absorption wavelength (see P45+/3. Results and discussion & Figs. 1-3).
7. The method according to claim 2, wherein the light-absorption/fluorescence characteristic(s) is a fluorescence spectrum or a fluorescence intensity, and wherein the aggregation state of the aggregative proteins is evaluated based on a relationship in which a maximum fluorescence intensity or a fluorescence intensity at a predetermined fluorescence wavelength (see P45+/3. Results and discussion & Figs. 1-3).
Conclusion
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/DEAN KWAK/Primary Examiner, Art Unit 1795
DEAN KWAK
Primary Examiner
Art Unit 1795
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