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. Upon considering the pre-appeal conference decision made on June 15, 2026, the finality of the office action has been withdrawn.
Status of the Application
2. Claims 1-15 are pending under examination. Claims 16-20 were previously withdrawn from further consideration as being drawn to nonelected group. The Applicant’s arguments have been fully considered and found persuasive in view of the pre-appeal conference decision. The rejections not reiterated herein are withdrawn in view of the pre-appeal conference decision.
New Rejections
Claim Rejections - 35 USC § 102
3. 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 1-2, 7-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pang et al. (Analytical Biochemistry, Vol. 574, p.1-6 (2019).
Pang et al. teach a detection reagent of claim 1, 9-10, for colorimetric detection of a nucleic acid amplification reaction, comprising two metal indicators, an amplification reaction buffer comprising said detection reagent (page 2, paragraph 1 under section 2.4 of Materials and Methods).
With reference to claim 2, Pang et al. teach that the two metal indicators comprising HNB and calcein (page 2, paragraph 1 under section 2.4 of Materials and Methods).
With reference to claim 7-8, Pang et al. teach that the amplification reaction is an isothermal amplification reaction, wherein the isothermal amplification is a loop-mediated isothermal amplification (LAMP) reaction (page 2, paragraph 1 under section 2.4 of Materials and Methods).
With reference to claim 13, Pang et al. teach that the nucleic acid amplification reaction further comprising one or more reagents comprising one or more amplification primers, polymerase, one buffer and dNTPs ((page 2, paragraph 1 under section 2.4 of Materials and Methods). For all the above the claims are anticipated.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pang et al. (Analytical Biochemistry, Vol. 574, p.1-6 (2019) in view of Turba et al. (US 2014/0329232).
Pang et al. teach a reaction composition as discussed above. Pang also teach a ratio of two metal indicators range between 0.5 to 2.0 (page 2, paragraphs under section 2.4). However, Pang et al. did not teach said two metal indicators comprising calmagite and a kit.
Turba et al. teach a nucleic acid amplification reaction comprising at least one metal indicator and a magnesium chelator and a kit comprising one or more primers, buffer (Tris-HCl buffer), a polymerase and at least one metal indicator and at least one magnesium chelator wherein the at least one metal indicator comprises calmagite (para 0024-0026, 0042-0045, 0079, 0156-0157).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the detection reagent as taught by Pang et al. with calmagite and a kit comprising said detection reagent as taught by Turba et al. to develop an improved detection reagent. The ordinary person skilled in the art would have motivated to combine the composition as taught by Pang with the teaching of Turba et al. and have a reasonable expectation of success that the combination would result in an improved detection reagent for nucleic acid amplification because Turba et al. explicitly taught use of at least one metal ion indicator wherein said at least one metal indicator comprises calmagite and a kit comprising said detection reagent that improves the sensitivity color changes in colorimetric detection of amplified nucleic acid (para 0024-0027) and such a modification of the claims is considered obvious over the cited art.
Conclusion
No claims are allowable.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
Prosecution Insights