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 .
DETAILED ACTION
1. The Applicant’s response to the office action filed on November 24, 2025 is acknowledged.
Status of the Application
2. Claims 1-15 are pending under examination. Claims 16-20 were withdrawn as being drawn to nonelected group. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-withdrawn
3. The objection to the specification has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112-Withdrawn
4. The rejection of claims 2-6 and 15 under 35 USC 112(b) has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102-Maintained
5. 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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ismagilov et al. (US 2018/0321137).
Ismagilov et al. teach a detection reagent of claim 1, 9-10, 14, for colorimetric detection of a nucleic acid amplification reaction, comprising two or more metal indicators, a buffer comprising said detection reagent and a kit comprising said detection reagent (para 0032, 0070, 0110, 0242, 0277, 0305).
With reference to claim 2, Ismagilov et al. teach that the two or more metal indicators
are selected from the group consisting of: Eriochrome™ Black t, hydroxynaphthol blue
(HNB), thymolphthalein complexone, methylthymol blue, xylidyl Blue I, xylidyl Blue II,
calcein, copper sulfate (CuSO4) and calmagite (para 0032, 0110, 0242, 0277, 0054).
With reference to claims 3-4, Ismagilov et al. teach that the two or more metal
indicators comprise HNB and calmagite or the two or more metal indicators consist
essentially of HNB and calmagite (para 0032, 0242, 0277, 0054).
With reference to claims 5-6, Ismagilov et al. teach that the molar ratio of HNB to
calmagite is between about 0.5:2 to about 2:0.5 or 1:1 (para 0242, 0277, 0070).
With reference to claim 7, Ismagilov et al. teach that the amplification reaction is an
isothermal amplification reaction selected from the group consisting of: a loop-mediated
isothermal amplification (LAMP) reaction, a helicase displacement amplification (HPA)
reaction, a strand displacement amplification, a recombinase polymerase amplification
reaction, a nicking enzyme amplification reaction (NEAR), an exponential amplification
reaction (EXPAR), a rolling circle amplification (RCA) reaction and a nucleic acid
sequence-based amplification (NASBA) reaction (para 0026-0027, 0236).
With reference to claim 8, Ismagilov et al. teach that the amplification reaction is loop-
mediated isothermal amplification (LAMP) (para 0026-0027).
With reference to claims 11-12, Ismagilov et al. teach that the nucleic acid
amplification buffer provides a pH between about 7 and about 10 in the nucleic acid
amplification reaction (para 0070).
With reference to claim 13, Ismagilov et al. teach that the nucleic acid amplification
reaction further comprising one or more reagents selected from the group consisting of:
one or more amplification primers, one or more polymerases, one or more buffers, and
one or more dNTPs (para 0263, 0305).
With reference to claim 15, Ismagilov et al. teach that a kit comprising the detection reagent and the kit comprising one or more reagents selected from the group consisting of: one or more amplification primers, one or more polymerases, one or more buffers, and one or more dNTPs (para 0263, 0305). For all the above the claims are anticipated.
Response to Arguments:
With reference to the rejection of claims 1-15 under 35 USC 102(a)(1) as being anticipated by Ismagilov, the Applicant’s arguments have been fully considered and found unpersuasive. With reference to the Applicant’s arguments drawn to no teaching of amplification reaction comprising two or more indicators and citing para 0053-0054 and 0242 to support their arguments, the arguments were found unpersuasive. As discussed in the rejection, Ismagilov et al. teach an amplification reaction comprising two or three metal indicators (para 0305 (example 5), 0032, 0070, 0110). The Applicant’s arguments drawn to para 0053-0054 and 0242 have been found unpersuasive because the cited paragraphs teach the wavelength detection of said indicators wherein wavelength of two-color combination teaches use of two indicators in a ratio as recited in the claims. For all the above the rejection has been maintained.
6. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Gee et al. has been withdrawn in view of persuasive arguments drawn to amplification reaction.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681