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 .
Response to Arguments
Applicant’s amendment and arguments (see page , filed November 26th, 2025, has overcome the previous rejection. Specifically, it appears that while Chou (WO 2014144133) teaches “wherein the background threshold is set using the Raman intensity that has the maximum sum of pixels, obtained by Raman analysis performed for a reagent which does not include the Raman active particles and a standard deviation” (⁋ bridging pages 25-26), it does not teach or render obvious “wherein the background threshold is set using the sum of maximum Raman intensities”. Chou appears to not consider the maximum Raman intensity.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
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, 4-11, and 14-16 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 recites the limitations "the total number of pixels", “the sum of maximum Raman intensities”, “the standard deviation” in lines 13-17. There is insufficient antecedent basis for this limitation in the claim.
Further, in regards to claim 1, it is not clear what is meant by “which does not include the Raman active particles and the standard deviation”? First, it is not clear what the “and the standard deviation” is tied to (i.e. is it that the background threshold is set using the sum of Raman intensities and a standard deviation or that the maximum Raman intensities is obtained by Raman analysis and using a standard deviation?). Also, what standard deviation is the claim referring to (i.e. a standard deviation of the background signal as a whole, the standard deviation of signals near the maximum Raman intensity, etc?). Clarification is required.
In regards to claims 10 and 15, which depends on claims 1 and 11, respectively, the claim states “a relative standard deviation”. As applicant has added a limitation in claim 1 disclosing “the standard deviation” it is unclear whether the relative standard deviation and the standard deviation are the same or different limitations. Clarification is required.
In regards to claim 11, this claim has all the issues as discussed with respect to claim 1 above. Further, claim 11 additionally recites the limitation "the background threshold” in line 20. There is insufficient antecedent basis for this limitation in the claim.
Any claim dependent upon a rejected claim, inherit the issues of the parent claim, and are, therefore, also rejected under 35 U.S.C. 112(b).
Allowable Subject Matter
Claims 1, 4-11, and 14-16 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
In regards to claim 1, the prior art neither discloses or renders obvious a digital surface-enhanced Raman scattering (SERS) sensing platform wherein a digital signal analysis unit which analyzes a quantitative detection signal of a substance to be detected by a combination of a Raman signal intensity calculated from the Raman spectrum and a digital count calculated from the Raman mapping, the digital count is the total number of pixels of which the Raman signal intensity is more than a background threshold in a Raman map obtained by the Raman mapping, wherein the background threshold is set using the sum of maximum Raman intensities obtained by Raman analysis performed for a reagent which does not include the Raman active particles and the standard deviation, and wherein the quantitative detection signal is a product of the Raman signal intensity and the digital count in combination with the rest of the limitations of the claim.
In regards to claim 11, the prior art neither discloses nor renders obvious a detection method of a substance to be detected in a sample, the method comprising e) obtaining a digital signal which is quantitatively detected by a combination of a Raman signal intensity calculated from the Raman spectrum and a digital count calculated from the Raman mappings wherein the digital count of e) is the total number of pixels of which the Raman signal intensity in the Raman map obtained by the Raman mapping performed in a predetermined area is more than the background threshold, wherein the background threshold is set using the sum of maximum Raman intensities obtained by Raman analysis performed for a reagent which does not include the Raman active particles and the standard deviation, and wherein the digital signal is a product of the Raman signal intensity and the digital count, in combination with the rest of the limitations of the claim.
As noted in the previous action, the closest prior art is You (WO 2021045288A1) in view of Chou (WO 2014144133). However, it appears that while Chou (WO 2014144133) teaches “wherein the background threshold is set using the Raman intensity that has the maximum sum of pixels, obtained by Raman analysis performed for a reagent which does not include the Raman active particles and a standard deviation” (⁋ bridging pages 25-26), it does not teach or render obvious “wherein the background threshold is set using the sum of maximum Raman intensities”. Chou appears to not consider the maximum Raman intensity.
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.
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/KARA E. GEISEL/
Art Unit 2877